variety of clinical presentations

Overview and General Information about Oral Presentation

• Daily Presentations During Work Rounds
• The New Patient Presentation
• The Holdover Admission Presentation
• Outpatient Clinic Presentations
• The structure of presentations varies from service to service (e.g. medicine vs. surgery), amongst subspecialties, and between environments (inpatient vs. outpatient). Applying the correct style to the right setting requires that the presenter seek guidance from the listeners at the outset.
• Time available for presenting is rather short, which makes the experience more stressful.
• Individual supervisors (residents, faculty) often have their own (sometimes quirky) preferences regarding presentation styles, adding another layer of variability that the presenter has to manage.
• Students are evaluated/judged on the way in which they present, with faculty using this as one way of gauging a student’s clinical knowledge.
• Done well, presentations promote efficient, excellent care. Done poorly, they promote tedium, low morale, and inefficiency.

General Tips:

• Practice, Practice, Practice! Do this on your own, with colleagues, and/or with anyone who will listen (and offer helpful commentary) before you actually present in front of other clinicians. Speaking "on-the-fly" is difficult, as rapidly organizing and delivering information in a clear and concise fashion is not a naturally occurring skill.
• Immediately following your presentations, seek feedback from your listeners. Ask for specifics about what was done well and what could have been done better – always with an eye towards gaining information that you can apply to improve your performance the next time.
• Listen to presentations that are done well – ask yourself, “Why was it good?” Then try to incorporate those elements into your own presentations.
• Listen to presentations that go poorly – identify the specific things that made it ineffective and avoid those pitfalls when you present.
• Effective presentations require that you have thought through the case beforehand and understand the rationale for your conclusions and plan. This, in turn, requires that you have a good grasp of physiology, pathology, clinical reasoning and decision-making - pushing you to read, pay attention, and in general acquire more knowledge.
• Think about the clinical situation in which you are presenting so that you can provide a summary that is consistent with the expectations of your audience. Work rounds, for example, are clearly different from conferences and therefore mandate a different style of presentation.
• Presentations are the way in which we tell medical stories to one another. When you present, ask yourself if you’ve described the story in an accurate way. Will the listener be able to “see” the patient the same way that you do? Can they come to the correct conclusions? If not, re-calibrate.
• It's O.K. to use notes, though the oral presentation should not simply be reduced to reading the admission note – rather, it requires appropriate editing/shortening.
• In general, try to give your presentations on a particular service using the same order and style for each patient, every day. Following a specific format makes it easier for the listener to follow, as they know what’s coming and when they can expect to hear particular information. Additionally, following a standardized approach makes it easier for you to stay organized, develop a rhythm, and lessens the chance that you’ll omit elements.

Specific types of presentations

There are a number of common presentation-types, each with its own goals and formats. These include:

• Daily presentations during work rounds for patients known to a service.
• Newly admitted patients, where you were the clinician that performed the H&P.
• Newly admitted patients that were “handed off” to the team in the morning, such that the H&P was performed by others.
• Outpatient clinic presentations, covering several common situations.

Key elements of each presentation type are described below. Examples of how these would be applied to most situations are provided in italics. The formats are typical of presentations done for internal medicine services and clinics.

Note that there is an acceptable range of how oral presentations can be delivered. Ultimately, your goal is to tell the correct story, in a reasonable amount of time, so that the right care can be delivered. Nuances in the order of presentation, what to include, what to omit, etc. are relatively small points. Don’t let the pursuit of these elements distract you or create undue anxiety.

Daily presentations during work rounds of patients that you’re following:

• Organize the presenter (forces you to think things through)
• Inform the listener(s) of 24 hour events and plan moving forward
• Promote focused discussion amongst your listeners and supervisors
• Opportunity to reassess plan, adjust as indicated
• Demonstrate your knowledge and engagement in the care of the patient
• Rapid (5 min) presentation of the key facts

Key features of presentation:

• Opening one liner: Describe who the patient is, number of days in hospital, and their main clinical issue(s).
• 24-hour events: Highlighting changes in clinical status, procedures, consults, etc.
• Subjective sense from the patient about how they’re feeling, vital signs (ranges), and key physical exam findings (highlighting changes)
• Relevant labs (highlighting changes) and imaging
• Assessment and Plan : Presented by problem or organ systems(s), using as many or few as are relevant. Early on, it’s helpful to go through the main categories in your head as a way of making sure that you’re not missing any relevant areas. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.

Example of a daily presentation for a patient known to a team:

• Opening one liner: This is Mr. Smith, a 65 year old man, Hospital Day #3, being treated for right leg cellulitis
• MRI of the leg, negative for osteomyelitis
• Evaluation by Orthopedics, who I&D’d a superficial abscess in the calf, draining a moderate amount of pus
• Patient appears well, states leg is feeling better, less painful
• T Max 101 yesterday, T Current 98; Pulse range 60-80; BP 140s-160s/70-80s; O2 sat 98% Room Air
• Ins/Outs: 3L in (2 L NS, 1 L po)/Out 4L urine
• Right lower extremity redness now limited to calf, well within inked lines – improved compared with yesterday; bandage removed from the I&D site, and base had small amount of purulence; No evidence of fluctuance or undrained infection.
• Creatinine .8, down from 1.5 yesterday
• WBC 8.7, down from 14
• Blood cultures from admission still negative
• Gram stain of pus from yesterday’s I&D: + PMNS and GPCs; Culture pending
• MRI lower extremity as noted above – negative for osteomyelitis
• Continue Vancomycin for today
• Ortho to reassess I&D site, though looks good
• Follow-up on cultures: if MRSA, will transition to PO Doxycycline; if MSSA, will use PO Dicloxacillin
• Given AKI, will continue to hold ace-inhibitor; will likely wait until outpatient follow-up to restart
• Add back amlodipine 5mg/d today
• Hep lock IV as no need for more IVF
• Continue to hold ace-I as above
• Wound care teaching with RNs today – wife capable and willing to assist. She’ll be in this afternoon.
• Set up follow-up with PMD to reassess wound and cellulitis within 1 week

The Brand New Patient (admitted by you)

• Provide enough information so that the listeners can understand the presentation and generate an appropriate differential diagnosis.
• Present a thoughtful assessment
• Present diagnostic and therapeutic plans
• Provide opportunities for senior listeners to intervene and offer input
• Chief concern: Reason why patient presented to hospital (symptom/event and key past history in one sentence). It often includes a limited listing of their other medical conditions (e.g. diabetes, hypertension, etc.) if these elements might contribute to the reason for admission.
• The history is presented highlighting the relevant events in chronological order.
• 7 days ago, the patient began to notice vague shortness of breath.
• 5 days ago, the breathlessness worsened and they developed a cough productive of green sputum.
• 3 days ago his short of breath worsened to the point where he was winded after walking up a flight of stairs, accompanied by a vague right sided chest pain that was more pronounced with inspiration.
• Enough historical information has to be provided so that the listener can understand the reasons that lead to admission and be able to draw appropriate clinical conclusions.
• Past history that helps to shed light on the current presentation are included towards the end of the HPI and not presented later as “PMH.” This is because knowing this “past” history is actually critical to understanding the current complaint. For example, past cardiac catheterization findings and/or interventions should be presented during the HPI for a patient presenting with chest pain.
• Where relevant, the patient's baseline functional status is described, allowing the listener to understand the degree of impairment caused by the acute medical problem(s).
• It should be explicitly stated if a patient is a poor historian, confused or simply unaware of all the details related to their illness. Historical information obtained from family, friends, etc. should be described as such.
• Review of Systems (ROS): Pertinent positive and negative findings discovered during a review of systems are generally incorporated at the end of the HPI. The listener needs this information to help them put the story in appropriate perspective. Any positive responses to a more inclusive ROS that covers all of the other various organ systems are then noted. If the ROS is completely negative, it is generally acceptable to simply state, "ROS negative.”
• Other Past Medical and Surgical History (PMH/PSH): Past history that relates to the issues that lead to admission are typically mentioned in the HPI and do not have to be repeated here. That said, selective redundancy (i.e. if it’s really important) is OK. Other PMH/PSH are presented here if relevant to the current issues and/or likely to affect the patient’s hospitalization in some way. Unrelated PMH and PSH can be omitted (e.g. if the patient had their gall bladder removed 10y ago and this has no bearing on the admission, then it would be appropriate to leave it out). If the listener really wants to know peripheral details, they can read the admission note, ask the patient themselves, or inquire at the end of the presentation.
• Medications and Allergies: Typically all meds are described, as there’s high potential for adverse reactions or drug-drug interactions.
• Family History: Emphasis is placed on the identification of illnesses within the family (particularly among first degree relatives) that are known to be genetically based and therefore potentially heritable by the patient. This would include: coronary artery disease, diabetes, certain cancers and autoimmune disorders, etc. If the family history is non-contributory, it’s fine to say so.
• Social History, Habits, other → as relates to/informs the presentation or hospitalization. Includes education, work, exposures, hobbies, smoking, alcohol or other substance use/abuse.
• Sexual history if it relates to the active problems.
• Vital signs and relevant findings (or their absence) are provided. As your team develops trust in your ability to identify and report on key problems, it may become acceptable to say “Vital signs stable.”
• Note: Some listeners expect students (and other junior clinicians) to describe what they find in every organ system and will not allow the presenter to say “normal.” The only way to know what to include or omit is to ask beforehand.
• Key labs and imaging: Abnormal findings are highlighted as well as changes from baseline.
• Summary, assessment & plan(s) Presented by problem or organ systems(s), using as many or few as are relevant. Early on, it’s helpful to go through the main categories in your head as a way of making sure that you’re not missing any relevant areas. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.
• The assessment and plan typically concludes by mentioning appropriate prophylactic considerations (e.g. DVT prevention), code status and disposition.
• Chief Concern: Mr. H is a 50 year old male with AIDS, on HAART, with preserved CD4 count and undetectable viral load, who presents for the evaluation of fever, chills and a cough over the past 7 days.
• Until 1 week ago, he had been quite active, walking up to 2 miles a day without feeling short of breath.
• Approximately 1 week ago, he began to feel dyspneic with moderate activity.
• 3 days ago, he began to develop subjective fevers and chills along with a cough productive of red-green sputum.
• 1 day ago, he was breathless after walking up a single flight of stairs and spent most of the last 24 hours in bed.
• Diagnosed with HIV in 2000, done as a screening test when found to have gonococcal urethritis
• Was not treated with HAART at that time due to concomitant alcohol abuse and non-adherence.
• Diagnosed and treated for PJP pneumonia 2006
• Diagnosed and treated for CMV retinitis 2007
• Became sober in 2008, at which time interested in HAART. Started on Atripla, a combination pill containing: Efavirenz, Tonofovir, and Emtricitabine. He’s taken it ever since, with no adverse effects or issues with adherence. Receives care thru Dr. Smiley at the University HIV clinic.
• CD4 count 3 months ago was 400 and viral load was undetectable.
• He is homosexual though he is currently not sexually active. He has never used intravenous drugs.
• He has no history of asthma, COPD or chronic cardiac or pulmonary condition. No known liver disease. Hepatitis B and C negative. His current problem seems different to him then his past episode of PJP.
• Review of systems: negative for headache, photophobia, stiff neck, focal weakness, chest pain, abdominal pain, diarrhea, nausea, vomiting, urinary symptoms, leg swelling, or other complaints.
• Hypertension x 5 years, no other known vascular disease
• Gonorrhea as above
• Alcohol abuse above and now sober – no known liver disease
• No relevant surgeries
• Atripla, 1 po qd
• Omeprazole 20 mg, 1 PO, qd
• Lisinopril 20mg, qd
• Naprosyn 250 mg, 1-2, PO, BID PRN
• No allergies
• Both of the patient's parents are alive and well (his mother is 78 and father 80). He has 2 brothers, one 45 and the other 55, who are also healthy. There is no family history of heart disease or cancer.
• Patient works as an accountant for a large firm in San Diego. He lives alone in an apartment in the city.
• Smokes 1 pack of cigarettes per day and has done so for 20 years.
• No current alcohol use. Denies any drug use.
• Sexual History as noted above; has sex exclusively with men, last partner 6 months ago.
• Seated on a gurney in the ER, breathing through a face-mask oxygen delivery system. Breathing was labored and accessory muscles were in use. Able to speak in brief sentences, limited by shortness of breath
• Vital signs: Temp 102 F, Pulse 90, BP 150/90, Respiratory Rate 26, O2 Sat (on 40% Face Mask) 95%
• HEENT: No thrush, No adenopathy
• Lungs: Crackles and Bronchial breath sounds noted at right base. E to A changes present. No wheezing or other abnormal sounds noted over any other area of the lung. Dullness to percussion was also appreciated at the right base.
• Cardiac: JVP less than 5 cm; Rhythm was regular. Normal S1 and S2. No murmurs or extra heart sounds noted.
• Abdomen and Genital exams: normal
• Extremities: No clubbing, cyanosis or edema; distal pulses 2+ and equal bilaterally.
• Skin: no eruptions noted.
• Neurological exam: normal
• WBC 18 thousand with 10% bands;
• Normal Chem 7 and LFTs.
• Room air blood gas: pH of 7.47/ PO2 of 55/PCO2 of 30.
• Sputum gram stain remarkable for an abundance of polys along with gram positive diplococci.
• CXR remarkable for dense right lower lobe infiltrate without effusion.
• Monitored care unit, with vigilance for clinical deterioration.
• Hypertension: given significant pneumonia and unclear clinical direction, will hold lisinopril. If BP > 180 and or if clear not developing sepsis, will consider restarting.
• Low molecular weight heparin
• Code Status: Wishes to be full code full care, including intubation and ICU stay if necessary. Has good quality of life and hopes to return to that functional level. Wishes to reconsider if situation ever becomes hopeless. Older brother Tom is surrogate decision maker if the patient can’t speak for himself. Tom lives in San Diego and we have his contact info. He is aware that patient is in the hospital and plans on visiting later today or tomorrow.
• Expected duration of hospitalization unclear – will know more based on response to treatment over next 24 hours.

The holdover admission (presenting data that was generated by other physicians)

• Handoff admissions are very common and present unique challenges
• Understand the reasons why the patient was admitted
• Review key history, exam, imaging and labs to assure that they support the working diagnostic and therapeutic plans
• Does the data support the working diagnosis?
• Do the planned tests and consults make sense?
• What else should be considered (both diagnostically and therapeutically)?
• This process requires that the accepting team thoughtfully review their colleagues efforts with a critical eye – which is not disrespectful but rather constitutes one of the main jobs of the accepting team and is a cornerstone of good care *Note: At some point during the day (likely not during rounds), the team will need to verify all of the data directly with the patient.
• 8-10 minutes
• Chief concern: Reason for admission (symptom and/or event)
• Temporally presented bullets of events leading up to the admission
• Review of systems
• Relevant PMH/PSH – historical information that might affect the patient during their hospitalization.
• Meds and Allergies
• Family and Social History – focusing on information that helps to inform the current presentation.
• Habits and exposures
• Physical exam, imaging and labs that were obtained in the Emergency Department
• Assessment and plan that were generated in the Emergency Department.
• Overnight events (i.e. what happened in the Emergency Dept. and after the patient went to their hospital room)? Responses to treatments, changes in symptoms?
• How does the patient feel this morning? Key exam findings this morning (if seen)? Morning labs (if available)?
• Assessment and Plan , with attention as to whether there needs to be any changes in the working differential or treatment plan. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.
• Chief concern: 70 yo male who presented with 10 days of progressive shoulder pain, followed by confusion. He was brought in by his daughter, who felt that her father was no longer able to safely take care for himself.
• 10 days ago, Mr. X developed left shoulder pain, first noted a few days after lifting heavy boxes. He denies falls or direct injury to the shoulder.
• 1 week ago, presented to outside hospital ER for evaluation of left shoulder pain. Records from there were notable for his being afebrile with stable vitals. Exam notable for focal pain anteriorly on palpation, but no obvious deformity. Right shoulder had normal range of motion. Left shoulder reported as diminished range of motion but not otherwise quantified. X-ray negative. Labs remarkable for wbc 8, creat 2.2 (stable). Impression was that the pain was of musculoskeletal origin. Patient was provided with Percocet and told to see PMD in f/u
• Brought to our ER last night by his daughter. Pain in shoulder worse. Also noted to be confused and unable to care for self. Lives alone in the country, home in disarray, no food.
• ROS: negative for falls, prior joint or musculoskeletal problems, fevers, chills, cough, sob, chest pain, head ache, abdominal pain, urinary or bowel symptoms, substance abuse
• Hypertension
• Coronary artery disease, s/p LAD stent for angina 3 y ago, no symptoms since. Normal EF by echo 2 y ago
• Chronic kidney disease stage 3 with creatinine 1.8; felt to be secondary to atherosclerosis and hypertension
• aspirin 81mg qd, atorvastatin 80mg po qd, amlodipine 10 po qd, Prozac 20
• Allergies: none
• Family and Social: lives alone in a rural area of the county, in contact with children every month or so. Retired several years ago from work as truck driver. Otherwise non-contributory.
• Habits: denies alcohol or other drug use.
• Temp 98 Pulse 110 BP 100/70
• Drowsy though arousable; oriented to year but not day or date; knows he’s at a hospital for evaluation of shoulder pain, but doesn’t know the name of the hospital or city
• CV: regular rate and rhythm; normal s1 and s2; no murmurs or extra heart sounds.
• Left shoulder with generalized swelling, warmth and darker coloration compared with Right; generalized pain on palpation, very limited passive or active range of motion in all directions due to pain. Right shoulder appearance and exam normal.
• CXR: normal
• EKG: sr 100; nl intervals, no acute changes
• WBC 13; hemoglobin 14
• Na 134, k 4.6; creat 2.8 (1.8 baseline 4 m ago); bicarb 24
• LFTs and UA normal
• Vancomycin and Zosyn for now
• Orthopedics to see asap to aspirate shoulder for definitive diagnosis
• If aspiration is consistent with infection, will need to go to Operating Room for wash out.
• Urine electrolytes
• Follow-up on creatinine and obtain renal ultrasound if not improved
• Renal dosing of meds
• Strict Ins and Outs.
• follow exam
• obtain additional input from family to assure baseline is, in fact, normal
• Since admission (6 hours) no change in shoulder pain
• This morning, pleasant, easily distracted; knows he’s in the hospital, but not date or year
• T Current 101F Pulse 100 BP 140/80
• Ins and Outs: IVF Normal Saline 3L/Urine output 1.5 liters
• L shoulder with obvious swelling and warmth compared with right; no skin breaks; pain limits any active or passive range of motion to less than 10 degrees in all directions
• Labs this morning remarkable for WBC 10 (from 13), creatinine 2 (down from 2.8)
• Continue with Vancomycin and Zosyn for now
• I already paged Orthopedics this morning, who are en route for aspiration of shoulder, fluid for gram stain, cell count, culture
• If aspirate consistent with infection, then likely to the OR
• Continue IVF at 125/h, follow I/O
• Repeat creatinine later today
• Not on any nephrotoxins, meds renaly dosed
• Continue antibiotics, evaluation for primary source as above
• Discuss with family this morning to establish baseline; possible may have underlying dementia as well
• SC Heparin for DVT prophylaxis
• Code status: full code/full care.

Outpatient-based presentations

There are 4 main types of visits that commonly occur in an outpatient continuity clinic environment, each of which has its own presentation style and purpose. These include the following, each described in detail below.

• The patient who is presenting for their first visit to a primary care clinic and is entirely new to the physician.
• The patient who is returning to primary care for a scheduled follow-up visit.
• The patient who is presenting with an acute problem to a primary care clinic
• The specialty clinic evaluation (new or follow-up)

It’s worth noting that Primary care clinics (Internal Medicine, Family Medicine and Pediatrics) typically take responsibility for covering all of the patient’s issues, though the amount of energy focused on any one topic will depend on the time available, acuity, symptoms, and whether that issue is also followed by a specialty clinic.

The Brand New Primary Care Patient

Purpose of the presentation

• Accurately review all of the patient’s history as well as any new concerns that they might have.
• Identify health related problems that need additional evaluation and/or treatment
• Provide an opportunity for senior listeners to intervene and offer input

Key features of the presentation

• If this is truly their first visit, then one of the main reasons is typically to "establish care" with a new doctor.
• It might well include continuation of therapies and/or evaluations started elsewhere.
• If the patient has other specific goals (medications, referrals, etc.), then this should be stated as well. Note: There may well not be a "chief complaint."
• For a new patient, this is an opportunity to highlight the main issues that might be troubling/bothering them.
• This can include chronic disorders (e.g. diabetes, congestive heart failure, etc.) which cause ongoing symptoms (shortness of breath) and/or generate daily data (finger stick glucoses) that should be discussed.
• Sometimes, there are no specific areas that the patient wishes to discuss up-front.
• Review of systems (ROS): This is typically comprehensive, covering all organ systems. If the patient is known to have certain illnesses (e.g. diabetes), then the ROS should include the search for disorders with high prevalence (e.g. vascular disease). There should also be some consideration for including questions that are epidemiologically appropriate (e.g. based on age and sex).
• Past Medical History (PMH): All known medical conditions (in particular those requiring ongoing treatment) are listed, noting their duration and time of onset. If a condition is followed by a specialist or co-managed with other clinicians, this should be noted as well. If a problem was described in detail during the “acute” history, it doesn’t have to be re-stated here.
• Past Surgical History (PSH): All surgeries, along with the year when they were performed
• Medications and allergies: All meds, including dosage, frequency and over-the-counter preparations. Allergies (and the type of reaction) should be described.
• Social: Work, hobbies, exposures.
• Sexual activity – may include type of activity, number and sex of partner(s), partner’s health.
• Smoking, Alcohol, other drug use: including quantification of consumption, duration of use.
• Family history: Focus on heritable illness amongst first degree relatives. May also include whether patient married, in a relationship, children (and their ages).
• Physical Exam: Vital signs and relevant findings (or their absence).
• Key labs and imaging if they’re available. Also when and where they were obtained.
• Summary, assessment & plan(s) presented by organ system and/or problems. As many systems/problems as is necessary to cover all of the active issues that are relevant to that clinic. This typically concludes with a “health care maintenance” section, which covers age, sex and risk factor appropriate vaccinations and screening tests.

The Follow-up Visit to a Primary Care Clinic

• Organize the presenter (forces you to think things through).
• Accurately review any relevant interval health care events that might have occurred since the last visit.
• Identification of new symptoms or health related issues that might need additional evaluation and/or treatment
• If the patient has no concerns, then verification that health status is stable
• Review of medications
• Provide an opportunity for listeners to intervene and offer input
• Reason for the visit: Follow-up for whatever the patient’s main issues are, as well as stating when the last visit occurred *Note: There may well not be a “chief complaint,” as patients followed in continuity at any clinic may simply be returning for a visit as directed by their doctor.
• Events since the last visit: This might include emergency room visits, input from other clinicians/specialists, changes in medications, new symptoms, etc.
• Review of Systems (ROS): Depth depends on patient’s risk factors and known illnesses. If the patient has diabetes, then a vascular ROS would be done. On the other hand, if the patient is young and healthy, the ROS could be rather cursory.
• PMH, PSH, Social, Family, Habits are all OMITTED. This is because these facts are already known to the listener and actionable aspects have presumably been added to the problem list (presented at the end). That said, these elements can be restated if the patient has a new symptom or issue related to a historical problem has emerged.
• MEDS : A good idea to review these at every visit.
• Physical exam: Vital signs and pertinent findings (or absence there of) are mentioned.
• Lab and Imaging: The reason why these were done should be mentioned and any key findings mentioned, highlighting changes from baseline.
• Assessment and Plan: This is most clearly done by individually stating all of the conditions/problems that are being addressed (e.g. hypertension, hypothyroidism, depression, etc.) followed by their specific plan(s). If a new or acute issue was identified during the visit, the diagnostic and therapeutic plan for that concern should be described.

The Focused Visit to a Primary Care Clinic

• Accurately review the historical events that lead the patient to make the appointment.
• Identification of risk factors and/or other underlying medical conditions that might affect the diagnostic or therapeutic approach to the new symptom or concern.
• Generate an appropriate assessment and plan
• Allow the listener to comment

Key features of the presentation:

• Reason for the visit
• History of Present illness: Description of the sequence of symptoms and/or events that lead to the patient’s current condition.
• Review of Systems: To an appropriate depth that will allow the listener to grasp the full range of diagnostic possibilities that relate to the presenting problem.
• PMH and PSH: Stating only those elements that might relate to the presenting symptoms/issues.
• PE: Vital signs and key findings (or lack thereof)
• Labs and imaging (if done)
• Assessment and Plan: This is usually very focused and relates directly to the main presenting symptom(s) or issues.

The Specialty Clinic Visit

Specialty clinic visits focus on the health care domains covered by those physicians. For example, Cardiology clinics are interested in cardiovascular disease related symptoms, events, labs, imaging and procedures. Orthopedics clinics will focus on musculoskeletal symptoms, events, imaging and procedures. Information that is unrelated to these disciples will typically be omitted. It’s always a good idea to ask the supervising physician for guidance as to what’s expected to be covered in a particular clinic environment.

• Highlight the reason(s) for the visit
• Review key data
• Provide an opportunity for the listener(s) to comment
• 5-7 minutes
• If it’s a consult, state the main reason(s) that the patient was referred as well as who referred them.
• If it’s a return visit, state the reasons why the patient is being followed in the clinic and when the last visit took place
• If it’s for an acute issue, state up front what the issue is Note: There may well not be a “chief complaint,” as patients followed in continuity in any clinic may simply be returning for a return visit as directed
• For a new patient, this highlights the main things that might be troubling/bothering the patient.
• For a specialty clinic, the history presented typically relates to the symptoms and/or events that are pertinent to that area of care.
• Review of systems , focusing on those elements relevant to that clinic. For a cardiology patient, this will highlight a vascular ROS.
• PMH/PSH that helps to inform the current presentation (e.g. past cardiac catheterization findings/interventions for a patient with chest pain) and/or is otherwise felt to be relevant to that clinic environment.
• Meds and allergies: Typically all meds are described, as there is always the potential for adverse drug interactions.
• Social/Habits/other: as relates to/informs the presentation and/or is relevant to that clinic
• Family history: Focus is on heritable illness amongst first degree relatives
• Physical Exam: VS and relevant findings (or their absence)
• Key labs, imaging: For a cardiology clinic patient, this would include echos, catheterizations, coronary interventions, etc.
• Summary, assessment & plan(s) by organ system and/or problems. As many systems/problems as is necessary to cover all of the active issues that are relevant to that clinic.
• Reason for visit: Patient is a 67 year old male presenting for first office visit after admission for STEMI. He was referred by Dr. Goins, his PMD.
• The patient initially presented to the ER 4 weeks ago with acute CP that started 1 hour prior to his coming in. He was found to be in the midst of a STEMI with ST elevations across the precordial leads.
• Taken urgently to cath, where 95% proximal LAD lesion was stented
• EF preserved by Echo; Peak troponin 10
• In-hospital labs were remarkable for normal cbc, chem; LDL 170, hdl 42, nl lfts
• Uncomplicated hospital course, sent home after 3 days.
• Since home, he states that he feels great.
• Denies chest pain, sob, doe, pnd, edema, or other symptoms.
• No symptoms of stroke or TIA.
• No history of leg or calf pain with ambulation.
• Prior to this admission, he had a history of hypertension which was treated with lisinopril
• 40 pk yr smoking history, quit during hospitalization
• No known prior CAD or vascular disease elsewhere. No known diabetes, no family history of vascular disease; He thinks his cholesterol was always “a little high” but doesn’t know the numbers and was never treated with meds.
• History of depression, well treated with prozac
• Discharge meds included: aspirin, metoprolol 50 bid, lisinopril 10, atorvastatin 80, Plavix; in addition he takes Prozac for depression
• Taking all of them as directed.
• Patient lives with his wife; they have 2 grown children who are no longer at home
• Works as a computer programmer
• Smoking as above
• ETOH: 1 glass of wine w/dinner
• No drug use
• No known history of cardiovascular disease among 2 siblings or parents.
• Well appearing; BP 130/80, Pulse 80 regular, 97% sat on Room Air, weight 175lbs, BMI 32
• Lungs: clear to auscultation
• CV: s1 s2 no s3 s4 murmur
• No carotid bruits
• ABD: no masses
• Ext; no edema; distal pulses 2+
• Cath from 4 weeks ago: R dominant; 95% proximal LAD; 40% Cx.
• EF by TTE 1 day post PCI with mild Anterior Hypokinesis, EF 55%, no valvular disease, moderate LVH
• Labs of note from the hospital following cath: hgb 14, plt 240; creat 1, k 4.2, lfts normal, glucose 100, LDL 170, HDL 42.
• EKG today: SR at 78; nl intervals; nl axis; normal r wave progression, no q waves
• Plan: aspirin 81 indefinitely, Plavix x 1y
• Given nitroglycerine sublingual to have at home.
• Reviewed symptoms that would indicate another MI and what to do if occurred
• Plan: continue with current dosages of meds
• Chem 7 today to check k, creatinine
• Plan: Continue atorvastatin 80mg for life
• Smoking cessation: Doing well since discharge without adjuvant treatments, aware of supports.
• Plan: AAA screening ultrasound

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How to present clinical cases

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• Ademola Olaitan , medical student 1 ,
• Oluwakemi Okunade , final year medical student 1 ,
• Jonathan Corne , consultant physician 2
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Presenting a patient is an essential skill that is rarely taught

Clinical presenting is the language that doctors use to communicate with each other every day of their working lives. Effective communication between doctors is crucial, considering the collaborative nature of medicine. As a medical student and later as a doctor you will be expected to present cases to peers and senior colleagues. This may be in the setting of handovers, referring a patient to another specialty, or requesting an opinion on a patient.

A well delivered case presentation will facilitate patient care, act a stimulus for timely intervention, and help identify individual and group learning needs. 1 Case presentations are also used as a tool for assessing clinical competencies at undergraduate and postgraduate level.

Medical students are taught how to take histories, examine, and communicate effectively with patients. However, we are expected to learn how to present effectively by observation, trial, and error.

Principles of presentation

Remember that the purpose of the case presentation is to convey your diagnostic reasoning to the listener. By the end of your presentation the examiner should have a clear view of the patient’s condition. Your presentation should include all the facts required to formulate a management plan.

There are no hard and fast rules for a perfect presentation, rather the content of each presentation should be determined by the case, the context, and the audience. For example, presenting a newly admitted patient with complex social issues on a medical ward round will be very different from presenting a patient with a perforated duodenal ulcer who is in need of an emergency laparotomy.

Whether you’re presenting on a busy ward round or during an objective structured clinical examination (OSCE), it is important that you are concise yet get across all the important points. Start by introducing patients with identifiers such as age, sex, and occupation, and move on to the complaint that they presented with or the reason that they are in hospital. The presenting complaint is an important signpost and should always be clearly stated at the start of the presentation.

Presenting a history

After you’ve introduced the patient and stated the presenting complaint, you can proceed in a chronological approach—for example, “Mr X came in yesterday with worsening shortness of breath, which he first noticed four days ago.” Alternatively you can discuss each of the problems, starting with the most pertinent and then going through each symptom in turn. This method is especially useful in patients who have several important comorbidities.

The rest of the history can then be presented in the standard format of presenting complaint, history of presenting complaint, medical history, drug history, family history, and social history. Strictly speaking there is no right or wrong place to insert any piece of information. However, in some instances it may be more appropriate to present some information as part of the history of presenting complaints rather than sticking rigidly to the standard format. For example, in a patient who presents with haemoptysis, a mention of relevant risk factors such as smoking or contacts with tuberculosis guides the listener down a specific diagnostic pathway.

Apart from deciding at what point to present particular pieces of information, it is also important to know what is relevant and should be included, and what is not. Although there is some variation in what your seniors might view as important features of the history, there are some aspects which are universally agreed to be essential. These include identifying the chief complaint, accurately describing the patient’s symptoms, a logical sequence of events, and an assessment of the most important problems. In addition, senior medical students will be expected to devise a management plan. 1

The detail in the family and social history should be adapted to the situation. So, having 12 cats is irrelevant in a patient who presents with acute appendicitis but can be relevant in a patient who presents with an acute asthma attack. Discerning the irrelevant from the relevant is not always easy, but it comes with experience. 2 In the meantime, learning about the diseases and their associated features can help to guide you in the things you need to ask about in your history. Indeed, it is impossible to present a good clinical history if you haven’t taken a good history from the patient.

Presenting examination findings

When presenting examination findings remember that the aim is to paint a clear picture of the patient’s clinical status. Help the listener to decide firstly whether the patient is acutely unwell by describing basics such as whether the patient is comfortable at rest, respiratory rate, pulse, and blood pressure. Is the patient pyrexial? Is the patient in pain? Is the patient alert and orientated? These descriptions allow the listener to quickly form a mental picture of the patient’s clinical status. After giving an overall picture of the patient you can move on to present specific findings about the systems in question. It is important to include particular negative findings because they can influence the patient’s management. For example, in a patient with heart failure it is helpful to state whether the patient has a raised jugular venous pressure, or if someone has a large thyroid swelling it is useful to comment on whether the trachea is displaced. Initially, students may find it difficult to know which details are relevant to the case presentation; however, this skill becomes honed with increasing knowledge and clinical experience.

Presenting in an exam

Although the same principles as presenting in other situations also apply in an exam setting, the exam situation differs in the sense that its purpose is for you to show your clinical competence to the examiner.

It’s all about making a good impression. Walk into the room confidently and with a smile. After taking the history or examining the patient, turn to the examiner and look at him or her before starting to present your findings. Avoid looking back at the patient while presenting. A good way to avoid appearing fiddly is to hold your stethoscope behind your back. You can then wring to your heart’s content without the examiner sensing your imminent nervous breakdown.

Start with an opening statement as you would in any other situation, before moving on to the main body of the presentation. When presenting the main body of your history or examination make sure that you show the examiner how your findings are linked to each other and how they come together to support your conclusion.

Finally, a good summary is just as important as a good introduction. Always end your presentation with two or three sentences that summarise the patient’s main problem. It can go something like this: “In summary, this is Mrs X, a lifelong smoker with a strong family history of cardiovascular disease, who has intermittent episodes of chest pain suggestive of stable angina.”

Improving your skills

The RIME model (reporter, interpreter, manager, and educator) gives the natural progression of the clinical skills of a medical student. 3 Early on in clinical practice students are simply reporters of information. As the student progresses and is able to link together symptoms, signs, and investigation results to come up with a differential diagnosis, he or she becomes an interpreter of information. With further development of clinical skills and increasing knowledge students are actively able to suggest management plans. Finally, managers progress to become educators. The development from reporter to manager is reflected in the student’s case presentations.

The key to improving presentation skills is to practise, practise, and then practise some more. So seize every opportunity to present to your colleagues and seniors, and reflect on the feedback you receive. 4 Additionally, by observing colleagues and doctors you can see how to and how not to present.

Remember the purpose of the presentation

Be flexible; the context should dictate the content of the presentation

Always include a presenting complaint

Present your findings in a way that shows understanding

Have a system

Use appropriate terminology

Additional tips for exams

Start with a clear introductory statement and close with a brief summary

After your summary suggest a working diagnosis and a management plan

Practise, practise, practise, and get feedback

Present with confidence, and don’t be put off by an examiner’s poker face

Be honest; do not make up signs to fit in with your diagnosis

Originally published as: Student BMJ 2010;18:c1539

Competing interests: None declared.

Provenance and peer review: Not commissioned; externally peer reviewed.

See “Medical ward rounds” ( Student BMJ 2009;17:98-9, http://archive.student.bmj.com/issues/09/03/life/98.php ).

• ↵ Green EH, Durning SJ, DeCherrie L, Fagan MJ, Sharpe B, Hershman W. Expectations for oral case presentations for clinical clerks: Opinions of internal medicine clerkship directors. J Gen Intern Med 2009 ; 24 : 370 -3. OpenUrl CrossRef PubMed Web of Science
• ↵ Lingard LA, Haber RJ. What do we mean by “relevance”? A clinical and rhetorical definition with implications for teaching and learning the case-presentation format. Acad Med 1999 ; 74 : S124 -7. OpenUrl CrossRef PubMed Web of Science
• ↵ Pangaro L. A new vocabulary and other innovations for improving descriptive in-training evaluations. Acad Med 1999 ; 74 : 1203 -7. OpenUrl CrossRef PubMed Web of Science
• ↵ Haber RJ, Lingard LA. Learning oral presentation skills: a rhetorical analysis with pedagogical and professional implications. J Gen Intern Med 2001 ; 16 : 308 -14. OpenUrl CrossRef PubMed Web of Science

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The Ultimate Patient Case Presentation Template for Med Students

• by Neelesh Bagrodia
• Apr 06, 2024
• Reviewed by: Amy Rontal, MD

Knowing how to deliver a patient presentation is one of the most important skills to learn on your journey to becoming a physician. After all, when you’re on a medical team, you’ll need to convey all the critical information about a patient in an organized manner without any gaps in knowledge transfer.

One big caveat: opinions about the correct way to present a patient are highly personal and everyone is slightly different. Additionally, there’s a lot of variation in presentations across specialties, and even for ICU vs floor patients.

My goal with this blog is to give you the most complete version of a patient presentation, so you can tailor your presentations to the preferences of your attending and team. So, think of what follows as a model for presenting any general patient.

Here’s a breakdown of what goes into the typical patient presentation.

7 Ingredients for a Patient Case Presentation Template

1. the one-liner.

The one-liner is a succinct sentence that primes your listeners to the patient.

A typical format is: “[Patient name] is a [age] year-old [gender] with past medical history of [X] presenting with [Y].

2. The Chief Complaint

This is a very brief statement of the patient’s complaint in their own words. A common pitfall is when medical students say that the patient had a chief complaint of some medical condition (like cholecystitis) and the attending asks if the patient really used that word!

An example might be, “Patient has chief complaint of difficulty breathing while walking.”

3. History of Present Illness (HPI)

The goal of the HPI is to illustrate the story of the patient’s complaint.

I remember when I first began medical school, I had a lot of trouble determining what was relevant and ended up giving a lot of extra details. Don’t worry if you have the same issue. With time, you’ll learn which details are important. 

The OPQRST Framework

In the beginning of your clinical experience, a helpful framework to use is OPQRST:

Describe when the issue started, and if it occurs during certain environmental or personal exposures.

P rovocative

Report if there are any factors that make the pain better or worse. These can be broad, like noting their shortness of breath worsened when lying flat, or their symptoms resolved during rest. 

Relay how the patient describes their pain or associated symptoms. For example, does the patient have a burning versus a pressure sensation? Are they feeling weakness, stiffness, or pain?

R egion/Location

Indicate where the pain is located and if it radiates anywhere.

Talk about how bad the pain is for the patient. Typically, a 0-10 pain scale is useful to provide some objective measure.

Discuss how long the pain lasts and how often it occurs.

A Case Study

While the OPQRST framework is great when starting out, it can be limiting.

Let’s take an example where the patient is not experiencing pain and comes in with altered mental status along with diffuse jaundice of the skin and a history of chronic liver disease. You will find that certain sections of OPQRST do not apply.

In this event, the HPI is still a story, but with a different framework. Try to go in chronological order. Include relevant details like if there have been any changes in medications, diet, or bowel movements.

Pertinent Positive and Negative Symptoms

Regardless of the framework you use, the name of the game is pertinent positive and negative symptoms the patient is experiencing.

I’d like to highlight the word “pertinent.” It’s less likely the patient’s chronic osteoarthritis and its management is related to their new onset shortness of breath, but it’s still important for knowing the patient’s complete medical picture. A better place to mention these details would be in the “Past Medical History” section, and reserve the HPI portion for more pertinent history.

As you become exposed to more illness scripts, experience will teach you which parts of the history are most helpful to state. Also, as you spend more time on the wards, you will pick up on which questions are relevant and important to ask during the patient interview.  

By painting a clear picture with pertinent positives and negatives during your presentation, the history will guide what may be higher or lower on the differential diagnosis.

Some other important components to add are the patient’s additional past medical/surgical history, family history, social history, medications, allergies, and immunizations.

The HEADSSS Method

Particularly, the social history is an important time to describe the patient as a complete person and understand how their life story may affect their present condition.

One way of organizing the social history is the HEADSSS method:

– H ome living situation and relationships – E ducation and employment – A ctivities and hobbies – D rug use (alcohol, tobacco, cocaine, etc.) Note frequency of use, and if applicable, be sure to add which types of alcohol consumption (like beer versus hard liquor) and forms of drug use. – S exual history (partners, STI history, pregnancy plans) – S uicidality and depression – S piritual and religious history  

Again, there’s a lot of variation in presenting social history, so just follow the lead of your team. For example, it’s not always necessary/relevant to obtain a sexual history, so use your judgment of the situation.

4. Review of Symptoms

Oftentimes, most elements of this section are embedded within the HPI. If there are any additional symptoms not mentioned in the HPI, it’s appropriate to state them here.

5. Objective

Vital signs.

Some attendings love to hear all five vital signs: temperature, blood pressure (mean arterial pressure if applicable), heart rate, respiratory rate, and oxygen saturation. Others are happy with “afebrile and vital signs stable.” Just find out their preference and stick to that. 

Physical Exam  

This is one of the most important parts of the patient presentation for any specialty. It paints a picture of how the patient looks and can guide acute management like in the case of a rigid abdomen. As discussed in the HPI section, typically you should report pertinent positives and negatives. When you’re starting out, your attending and team may prefer for you to report all findings as part of your learning.

For example, pulmonary exam findings can be reported as: “Regular chest appearance. No abnormalities on palpation. Lungs resonant to percussion. Clear to auscultation bilaterally without crackles, rhonchi, or wheezing.”

Typically, you want to report the physical exams in a head to toe format: General Appearance, Mental Status, Neurologic, Eyes/Ears/Nose/Mouth/Neck, Cardiovascular, Pulmonary, Breast, Abdominal, Genitourinary, Musculoskeletal, and Skin. Depending on the situation, additional exams can be incorporated as applicable.

Now comes reporting pertinent positive and negative labs. Several labs are often drawn upon admission. It’s easy to fall into the trap of reading off all the labs and losing everyone’s attention. Here are some pieces of advice: 

You normally can’t go wrong sticking to abnormal lab values. 

One qualification is that for a patient with concern for acute coronary syndrome, reporting a normal troponin is essential. Also, stating the normalization of previously abnormal lab values like liver enzymes is important.

Demonstrate trends in lab values.

A lab value is just a single point in time and does not paint the full picture. For example, a hemoglobin of 10g/dL in a patient at 15g/dL the previous day is a lot more concerning than a patient who has been stable at 10g/dL for a week.

Try to avoid editorializing in this section.

Save your analysis of the labs for the assessment section. Again, this can be a point of personal preference. In my experience, the team typically wants the raw objective data in this section.

This is also a good place to state the ins and outs of your patient (if applicable). In some patients, these metrics are strictly recorded and are typically reported as total fluid in and out over the past day followed by the net fluid balance. For example, “1L in, 2L out, net -1L over the past 24 hours.”

6. Diagnostics/Imaging

Next, you’ll want to review any important diagnostic tests and imaging. For example, describe how the EKG and echo look in a patient presenting with chest pain or the abdominal CT scan in a patient with right lower quadrant abdominal pain.

Try to provide your own interpretation to develop your skills and then include the final impression. Also, report if a diagnostic test is still pending.

7. Assessment/Plan

This is the fun part where you get to use your critical thinking (aka doctor) skills! For the scope of this blog, we’ll review a problem-based plan.

It’s helpful to begin with a summary statement that incorporates the one-liner, presenting issue(s)/diagnosis(es), and patient stability.

Then, go through all the problems relevant to the admission. You can impress your audience by casting a wide differential diagnosis and going through the elements of your patient presentation that support one diagnosis over another. 

Following your assessment, try to suggest a management plan. In a patient with congestive heart failure exacerbation, initiating a diuresis regimen and measuring strict ins/outs are good starting points.

You may even suggest a follow-up on their latest ejection fraction with an echo and check if they’re on guideline-directed medical therapy. Again, with more time on the clinical wards you’ll start to pick up on what management plan to suggest.

One pointer is to talk about all relevant problems, not just the presenting issue. For example, a patient with diabetes may need to be put on a sliding scale insulin regimen or another patient may require physical/occupational therapy. Just try to stay organized and be comprehensive.

A Note About Patient Presentation Skills

When you’re doing your first patient presentations, it’s common to feel nervous. There may be a lot of “uhs” and “ums.”

Here’s the good news: you don’t have to be perfect! You just need to make a good faith attempt and keep on going with the presentation.

With time, your confidence will build. Practice your fluency in the mirror when you have a chance. No one was born knowing medicine and everyone has gone through the same stages of learning you are!

Practice your presentation a couple times before you present to the team if you have time. Pull a resident aside if they have the bandwidth to make sure you have all the information you need. 

One big piece of advice: NEVER LIE. If you don’t know a specific detail, it’s okay to say, “I’m not sure, but I can look that up.” Someone on your team can usually retrieve the information while you continue on with your presentation.

Example Patient Case Presentation Template

Here’s a blank patient case presentation template that may come in handy. You can adapt it to best fit your needs.  

Chief Complaint:

History of Present Illness:

Past Medical History:

Past Surgical History:

Family History:

Social History:

Medications:

Immunizations:

Vital Signs : Temp ___ BP ___ /___ HR ___ RR ___ O2 sat ___

Physical Exam:

General Appearance:

Mental Status:

Neurological:

Eyes, Ears, Nose, Mouth, and Neck:

Cardiovascular:

Genitourinary:

Musculoskeletal:

Most Recent Labs:

Previous Labs:

Diagnostics/Imaging:

Impression/Interpretation:

Assessment/Plan:

One-line summary:

#Problem 1:

Assessment:

#Problem 2:

Final Thoughts on Patient Presentations

I hope this post demystified the patient presentation for you. Be sure to stay organized in your delivery and be flexible with the specifications your team may provide.  

Something I’d like to highlight is that you may need to tailor the presentation to the specialty you’re on. For example, on OB/GYN, it’s important to include a pregnancy history. Nonetheless, the aforementioned template should set you up for success from a broad overview perspective.  

Stay tuned for my next post on how to give an ICU patient presentation. And if you’d like me to address any other topics in a blog, write to me at [email protected] !

Looking for more (free!) content to help you through clinical rotations? Check out these other posts from Blueprint tutors on the Med School blog:

• How I Balanced My Clinical Rotations with Shelf Exam Studying
• How (and Why) to Use a Qbank to Prepare for USMLE Step 2
• How to Study For Shelf Exams: A Tutor’s Guide

About the Author

Hailing from Phoenix, AZ, Neelesh is an enthusiastic, cheerful, and patient tutor. He is a fourth year medical student at the Keck School of Medicine of the University of Southern California and serves as president for the Class of 2024. He is applying to surgery programs for residency. He also graduated as valedictorian of his high school and the USC Viterbi School of Engineering, obtaining a B.S. in Biomedical Engineering in 2020. He discovered his penchant for teaching when he began tutoring his friends for the SAT and ACT in the summer of 2015 out of his living room. Outside of the academic sphere, Neelesh enjoys surfing at San Onofre Beach and hiking in the Santa Monica Mountains. Twitter: @NeeleshBagrodia LinkedIn: http://www.linkedin.com/in/neelesh-bagrodia

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3 types of medical presentations (and how to give them)

Here are some tips for presenting the top three types of medical presentations: lectures, research presentations, and case reports.

Derek Murray

Building presentations

With your long to-do list as a medical professional, giving presentations is probably not a high priority. Yet, medical presentations are inevitable. Are you ready to give them when your job requires it? If so, where do you even start?

We want to make it a little easier for you to present data-heavy medical topics in an easy-to-understand way.

So, let’s dive right in with the top three types of medical presentations.

Key Takeaways:

• Structure your medical presentation into a story to make it memorable.
• Medical presentations can be lectures, research, or case presentations.
• Customize the presentation based on the type and goal.

1. Lectures

Medical lectures educate an audience about a medical topic. They’re one of the most challenging presentations. According to the Learning Pyramid , lectures are the most passive learning techniques, which is also why they have the lowest retention rates.

There are several settings for educational lectures, including:

• Conferences
• University or school lectures

Medical lectures help students or an audience comprehend complex medical information and then turn what they learned into actionable strategies.

For example, you may teach students with little medical knowledge about a new medical concept. But they must understand the topic and be able to recall it for examinations.

Tips for giving medical lectures

How can you turn one of the most challenging presentations into an engaging, memorable lecture? Here are a few tips to ace your educational medical lectures:

• Be interactive : Use Q&As, activities, and open discussions.
• Hand out resources: Give physical booklets students can review after the presentation.
• Use multimedia: Add audio-visual elements like images, video, and audio clips.
• Use simple language: Your audience is learning, so they need simple language and plenty of definitions to understand the topic.
• Make it entertaining: Keep your audience’s attention with a more engaging and entertaining presentation.

UnitedHealth Group incorporated imagery and movement to show rather than tell about mental health in 2022 to boost their engagement on the topic.

2. Research presentations

The most information-heavy medical presentation is the research presentation. Research presentations share findings with experienced medical professionals, usually in conference settings. Some of the audience includes:

• Investigators
• Ph.D. students
• Medical professionals and experienced doctors

Research presentations can also be part of healthcare marketing . You may have to introduce a new process, pharmaceutical, or device to encourage other healthcare professionals to adopt it in their practices.

Tips for giving research presentations

Use these tips to improve your research presentations :

• Speak on a higher level: You’re talking to a knowledgeable audience, so they expect a higher level of research.
• Back all facts with data: Use statistics and research to back all claims.
• Use power poses: Build authority with a confident presentation.
• Grab the audience’s attention: Start your presentation by giving your audience a reason to care, like a problem you want to solve.
• Build up the conclusion: Structure the research in a natural, progressive order that builds up to your conclusion.
• Look at the future: Conclude with how the research findings will impact the future of medicine.
• Visualize data : Simplify findings and data with visuals and charts.

Cardinal Health transformed the complex research for Smart Compression into understandable slides using a mix of graphics and storytelling in their medical presentation.

3. Case reports

Medical professionals must give oral case reports when transferring information between providers or a team. These presentations are very brief and often don’t require visuals.

Sometimes a case is especially unique and offers educational value to others. In that case, presenters should transform their quick oral case reports into a longer presentation that incorporates data and visuals.

Tips for giving case reports

Case reports use a similar structure to oral patient presentations, except with more details about each point. You’ll still want to pack as much information in a short presentation as possible.

• Begin the presentation with a patient overview: Start by introducing the patient, including all relevant demographic details in summarized graphics and lists.
• Present the history of the patient: Describe the patient’s history, why they sought care, and the symptoms they presented in charts and visuals.
• Explore medical information: Dive into the medical details, like treatment and history, using a storytelling structure to connect the information.
• Offer a plan: Outline a treatment plan alongside proof.

Summarize details in charts: You’ll pack a large amount of information in a concise presentation, so use plenty of charts and diagrams to summarize data and simplify outcomes.

Tips for preparing engaging medical presentations

Your medical presentations have highly complex topics rich with data. These topics can easily feel overwhelming or even boring if they don’t have the right structure and appearance.

Here are three medical presentation tips we’ve learned to help you prepare and present high-quality medical presentations that engage AND inform.

Know your audience’s knowledge level

Before building and presenting a medical topic, you must know your audience’s knowledge level. A lecture to a class of first-year college students will sound far different from a presentation to doctors with 10+ years of industry experience.

Build a presentation around your audience’s knowledge, so it’s understandable yet challenging. By taking this extra step, you’ll know what points need more explanation and what topics you can dig deeper into based on your audience’s experience.

Build a structured story

A complex topic becomes easy to understand and follow if you use a storytelling structure . You might ask, “How can a lecture on a new treatment be a story?”

Any time you communicate, it’s a story: You have the challenge to solve, potential solutions to try, and a final winner (like when presenting medical research). You can structure that story in a progressive order or by announcing one primary outcome and providing a list of proofs (like with patient case studies).

Focus on a goal

The goal of medical presentations can be educating, training, or persuading the audience, depending on the type of medical presentation. Knowing your goal guides which data is most relevant to bring your desired outcome.

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You’ll have an engaging and clear presentation deck in minutes rather than hours. Take back your time and communicate efficiently with Prezent so you can focus on turning your ideas and insights into action.

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Top 10 Clinical Trials PPT Templates with Samples and Examples

Anushka Bansal

Clinical trials caught public attention on a global scale during the Covid-19 pandemic. After much deliberation, we finally arrived at a vaccine for that once-in-a-century disease to hit the human race. 

Yet, an inescapable reality that is now near-household knowledge is that new lines of treatment to existing or new human diseases  emerge from rigorous scientific exploration and not some magic potion. That's indeed the realm of clinical trials, where volunteers become pioneers, testing the efficacy and safety of potential game-changers in healthcare. 

But why are these clinical trials so crucial, and how do they navigate the path from lab bench to bedside?

Clinical trials, the backbone of medical progress, hold significant importance in developing safe and effective treatments. These  scientifically-designed studies evaluate new drugs, devices, and interventions on human volunteers, paving the way for potential breakthroughs. They answer the critical question: "Does this treatment work, and is it safe?" Without clinical trials , promising therapies remain mere possibilities, locked away from the patients who desperately need them. Trials pave the way for better drugs, treatments, and devices, saving lives and improving countless others.

Typically, trials progress through distinct phases:

• Phase 1: Small-scale studies assess safety and dosage in healthy volunteers.
• Phase 2: Larger groups with the target condition receive the intervention, evaluating its efficacy and safety.
• Phase 3: Even larger trials confirm effectiveness and compare the intervention to existing treatments or placebo.
• Phase 4: Post-marketing surveillance monitors long-term safety and effectiveness in real-world settings.

There are s types of clinical trials. Observational studies track participants without intervention, gathering data on natural disease progression. Interventional studies actively manipulate variables, like testing a new drug against a control group.  In Randomized controlled trials, participants are randomly assigned to intervention or control groups, minimizing bias.

While there are variable forms of clinical trials maintaining a structured flow is crucial. Rigorous guidelines ensure ethical conduct, data quality, and participant safety. This is where Clinical Trials Templates come in handy. These pre-defined outlines guide researchers through each phase, ensuring compliance with the most-rigorous quality standards and facilitating efficient trial execution. These PPT Templates are 100% editable, customizable, and content-ready; they provide a structure to build your trial approach and strategy.

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Templ ate 1: Multiple Phases of Clinical Trial with Milestones PPT Template

This  PPT Template is tailored to provide an overview of the clinical trial process for lay audiences. It comprises four main sections: Preclinical, detailing initial lab and animal testing; Phases 1, 2, and 3, illustrating human testing stages; FDA Review, explaining the regulatory evaluation by the Food and Drug Administration; and Phase 4, highlighting post-approval drug monitoring. Each section offers text boxes for  details, allowing customization with information such as phase-specific goals, data types, and participant risks and benefits. Download Now!

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T emplate 2: Clinical Trial Phases with Objective and Timeline PPT Template

This template features four sections outlining distinct phases of the clinical trial process. "Lab Studies" addresses preclinical testing in the laboratory before human trials. "Phase I" focuses on initial human testing, primarily evaluating drug safety. "Phase II/III" encompasses the subsequent stages, emphasizing efficacy assessment. Lastly, "Phase IV" delves into post-marketing surveillance, ensuring long-term safety monitoring.  This template aids comprehension with customizable options for text, images, and charts. Download Now

Template 3: Multiple Phases of Clinical Trial with Outcomes PPT Template

Use this PPT Template to offer a comprehensive overview of clinical trial phases, detailing typical outcomes. The first section, "Phase I," centers on safety evaluation with 20-100 participants. "Phase II" follows, testing drug efficacy in a larger group (100-300 participants). "Phase III" compares the new drug to standards or placebos in a range between 300 and 3,000 participants, confirming efficacy and safety. The fourth section, "Phase IV," focuses on post-approval, monitoring the long-term safety and effectiveness for public use. This structured template efficiently communicates the progression and objectives of each phase, aiding understanding of the clinical trial process and outcomes. 

Te mplate 4: Clinical Trials Phases with Discovery Science PPT Template

This comprehensive overview divides  clinical trials into Discovery Science and Clinical Trials sections. The PPT Template highlights that the Discovery Science covers initial lab research, while the Clinical Trials section delineates four phases. Phase 0 assesses drug safety in 10-20 patients; Phase I involves 20-100 patients, focusing on safety, dosage, and side effects; Phase II expands to evaluate efficacy, safety, and dosage in several hundred patients; Phase III, with thousands of participants, compares the new drug's efficacy and safety to a standard treatment or placebo. With a clear and concise layout, this slide is a perfect fit for researchers, pharmaceutical entities, patients, and those interested in drug and therapy development.

Templ ate 5: Multistage Clinical Trial Phases with Licensing PPT Template

 Get a visual overview of the clinical trial process, from the initial stages of research to drug approval and licensing with this PPT Template. It features a funnel graphic with four sections, each representing a phase of clinical trials. The first section, labeled "Phase I", focuses on safety testing on a small  group of volunteers, typically 20-100 people. The second and third sections, labeled "Phase II" and "Phase III" respectively, involve testing the drug's efficacy in larger groups of volunteers, typically ranging between  100 and  3,000 people. The final section, labeled "Licensing", depicts the approval process by regulatory authorities and the drug's subsequent availability for sale. Download Now

Template 6: Multistage Clinical Trial Phases with Cost Involved PPT Template

This PPT Template  offers an infographic representation of the clinical trial process, divided into Preclinical Studies and Clinical Trial Phases, with associated timelines and costs. Preclinical Studies encompass lab research, chemical testing, animal testing, and industrial development. Clinical Trial Phases detail Phase I's 2-month to 1-year safety testing, Phase II's one-three year efficacy testing in a larger group, Phase III's 3-5-year large-scale confirmation of efficacy and safety, and Phase IV post-marketing surveillance for long-term safety and efficacy. This slide  caters to researchers, pharmaceutical entities, patients, and those intrigued by new drug and therapy development, facilitating a comprehensive understanding of the process and associated costs. Download Now!

Te mplate 7: Clinical Trial Phases with Capitalized Cost and Probability of Attrition PPT Template

Know the entire clinic trial process, spanning  target validation and lead selection to regulatory approval submission. Divided into three sections, it covers the  journey and enables you to plan your trial phases. The first section provides a broad understanding of the clinical trial process, while the second delves into detailed information on each phase. The third section includes  data on capitalized costs, attrition probabilities, and the number of programs advancing through each phase. Download Now!

Templa te 8: Clinical Trial Phases with Development and Product Surveillance PPT Template

Get insight into clinical trial phases in the development of new drugs or medical devices. Divided into five sections, it begins with Basic Research, progresses through Preclinical Tests involving animal assessments, and then navigates the three phases of Clinical Tests in humans. The Registration phase involves submitting applications to regulatory agencies, such as the FDA, for market approval, followed by Product Surveillance for ongoing safety and efficacy monitoring post-market launch. Including timeframes and drug compounds filtered at each stage, this PPT Template serves as an educational resource for understanding the nuanced journey from research to market approval. Download Now!

Template 9: Clinical Trial Phases Results with Success Percentage PPT Template

 Know how to see and visualize clinical trial success rates across four phases with this nuanced PPT Template. The slide also  details  participant numbers and progression percentages. The Clinical Trial Phases section illustrates success rates from Phase I to IV, indicating, for instance, that 56.2% advance from Phase I to Phase II and 16.3% from Phase II to Phase III. The second section delves into Single Subject and Phase II/III Studies. The slide also explains the  use of single-subject studies for safety and efficacy testing in a single patient and Phase II/III studies for drug comparison. This template serves as a valuable resource, presenting complex trial data in an accessible format for presentations and educational materials.

Template 10: Graph Highlighting Cost Involved in Multiple Clinical Trial Phases PPT Template

Present the costs associated with each phase of clinical trials for new drugs with this PPT Template. It features a bar graph that shows the average cost for each phase, ranging from Phase 0 to Phase IV. The slide also includes the total average cost across all phases. There are placeholders for text boxes where you can insert insights and additional information.

CLINICAL TRIALS SAVE LIVES

Clinical trials are crucial for testing new drugs, devices, and treatments before they reach the public, ensuring safety and efficacy. Use our PPT templates for standardizing this process with clinical trial templates to streamline design, data collection, and analysis, saving time and resources while maintaining quality and ethical standards. 

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Acne: clinical presentations

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• 1 Department of Dermatology, SUNY Downstate Medical Center, 450 Clarkson Avenue, Brooklyn, NY 11203, USA. [email protected]
• PMID: 15556723
• DOI: 10.1016/j.clindermatol.2004.03.012

Acne vulgaris, the most common disease of the skin, can be manifested in a wide variety of clinical presentations. As a result of this clinical variation, there are almost as many classifications of acne as there are clinicians with particular interest in the disease. Thus acne has been classified as types I-IV, inflammatory versus noninflammatory, comedonal, comedopapular, papular, papulopustular, pustular, and "cystic" or nodular (even nodular-cystic). For those who are enamored of classification, there are subdivisions of the various categories, including "sandpaper comedones" and microcysts. There is even disagreement as to what constitutes a papule versus a nodule. The classic textbook definition of a nodule refers to lesions 1 cm or larger, but the early investigators of oral isotretinoin defined nodules as 4 mm or larger, and this definition has creeped into many texts, recently clarified by Bologna.(1)

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Cardiac imaging indications (webcast), friday, may 17, 2024 at 12:00 pm.

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A variety of clinical presentations including dyspnea, chest pain, syncope and palpitations may arouse suspicion of cardiovascular disease. Following a clinical history and examination, imaging of the heart may be required. Cardiac imaging is also used to monitor patients with known pathology in many cardiovascular diseases such as interval monitoring of aortic stenosis. Cardiac Imaging Indications is the topic of this week’s East Hospital Grand Rounds. Thura Harfi, MD, and Karolina Zareba, MD, bot Associate Professors of Internal Medicine, and are the expert panelist in this MedNet 21 webcast moderated by Shengyi Mao, MD, Associate Professor of Internal Medicine, and Medical Editor of MedNet 21. This presentation will be available as an in-person presentation in Wallace Auditorium beginning at 12:00 noon, today, May 17. Box lunches or lunch vouchers will be available to participants on a first-come basis.

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As a result of this educational activity, participants will be able to: - Describe the difference in image acquisition and clinical applications of CAC scan and Coronary CT angiography. - Discuss appropriate selection criteria of stress test modality vs CCTA in chest pain patients. - Discuss the comprehensive nature of evaluation with cardiac MRI. - Identify main indications for cardiac MRI.

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The Ohio State University designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit (s) ™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.

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Clinical Signs and Symptoms of Chikungunya Virus Disease

• Chikungunya virus disease should be suspected in patients with acute fever and polyarthralgia and recent travel to an area with chikungunya virus.
• Several other viruses, including dengue, should be considered in the differential diagnosis depending on travel history and exposures.
• Rare and serious complications of chikungunya virus disease can occur, particularly among certain risk groups.
• Disease is usually self-limited, but some patients experience persistent arthralgia for months to years.

Clinical presentation

Chikungunya virus disease should be considered in patients with acute onset of fever and polyarthralgia, especially travelers who recently returned from areas with known virus transmission.

The differential diagnosis varies based on place of residence, travel history, and exposures. Dengue, Zika, and chikungunya viruses are transmitted by the same mosquitoes and have similar clinical features. These viruses can circulate in the same area and can cause occasional co-infections in the same patient. Chikungunya virus infection is more likely to cause high fever, severe arthralgia, arthritis, rash, and lymphopenia, while dengue virus infection is more likely to cause neutropenia, thrombocytopenia, hemorrhage, shock, and death. In general, the signs and symptoms of Zika virus are mild, though infections can cause congenital infections. It is important to rule out dengue virus infection because proper clinical management of dengue can improve outcome.

In addition to dengue and Zika, other diagnostic considerations include leptospirosis, malaria, rickettsia, group A streptococcus, rubella, measles, parvovirus, enteroviruses, adenovirus, other alphavirus infections (Mayaro, Ross River, Barmah Forest, o’nyong-nyong, and Sindbis viruses), post-infectious arthritis, and rheumatologic conditions.

Signs and symptoms

The majority of people infected with chikungunya virus become symptomatic. The incubation period is typically 3–7 days (range, 1–12 days).

The disease is most often characterized by acute onset of fever (typically >39°C [102°F]) and polyarthralgia. Joint symptoms are usually bilateral and symmetric and can be severe and debilitating. Other symptoms can include headache, myalgia, arthritis, conjunctivitis, nausea/vomiting, or maculopapular rash. Rare complications include uveitis, retinitis, myocarditis, hepatitis, nephritis, bullous skin lesions, hemorrhage, meningoencephalitis, myelitis, Guillain-Barré syndrome, and cranial nerve palsies.

Persons at risk for severe disease include neonates exposed intrapartum or shortly after birth, older adults (>65 years), and persons with underlying medical conditions (e.g., hypertension, diabetes, or cardiovascular disease).

Clinical assessment

Clinical laboratory findings can include lymphopenia, thrombocytopenia, and elevated creatinine. Elevated hepatic transaminases can be seen with acute infection but are not specific and do not occur frequently enough to be diagnostic.

Acute symptoms typically resolve within 7–10 days. Some patients may have persistence or relapse of rheumatologic symptoms (polyarthralgia, polyarthritis, tenosynovitis) in the months following acute illness. Studies report variable proportions of patients with persistent joint pains for months to years. Mortality is rare and occurs mostly in older adults.

• CDC Yellow Book Chapter: Chikungunya
• Medscape CDC Expert Commentary: Differentiating Chikungunya from Dengue: A Clinical Challenge
• Sharp TM, Keating MK, Shieh WJ, Bhatnagar J, Bollweg BC, Levine R, et al. Clinical characteristics, histopathology, and tissue immunolocalization of chikungunya virus antigen in fatal cases. Clin Infect Dis . 2021;73(2):e345-e354. doi: 10.1093/cid/ciaa837
• Hsu CH, Cruz-Lopez F, Vargas Torres D, Perez-Padilla J, Lorenzi OD, Rivera A, et al. Risk factors for hospitalization of patients with chikungunya virus infection at sentinel hospitals in Puerto Rico. PLoS Negl Trop Dis . 2019;13(1):e0007084. doi: 10.1371/journal.pntd.0007084
• Lindsey NP, Staples JE, Fischer M. Chikungunya virus disease among travelers–United States, 2014-2016. Am J Trop Med Hyg . 2018;98(1):192-197. doi: 10.4269/ajtmh.17-0668
• Adams LE, Martin SW, Lindsey NP, Lehman JA, Rivera A, Kolsin J, et al. Epidemiology of dengue, chikungunya, and Zika virus disease in U.S. states and territories, 2017. Am J Trop Med Hyg . 2019;101(4):884-890. doi: 10.4269/ajtmh.19-0309
• Centers for Disease Control and Prevention. Notes from the Field: Chikungunya Virus Spreads in the Americas — Caribbean and South America, 2013–2014. MMWR Morb Mortal Wkly Rep . 2014;63(22);500-501.
• Leparc-Goffart I, Nougairede A, Cassadou S, Prat C, de Lamballerie X. Chikungunya in the Americas. Lancet . 2014;383(9916):514. doi: 10.1016/S0140-6736(14)60185-9
• Thiberville SD, Moyen N, Dupuis-Maguiraga L, Nougairede A, Gould EA, Roques P, de Lamballerie X. Chikungunya fever: epidemiology, clinical syndrome, pathogenesis and therapy. Antiviral Res . 2013;99:345–370. doi: 10.1016/j.antiviral.2013.06.009
• Gibney KB, Fischer M, Prince HE, Kramer LD, St. George K, Kosoy OL, et al. Chikungunya fever in the United States: a fifteen year review of cases. Clin Infect Dis . 2011;52(5):e121-e126. doi: 10.1093/cid/ciq214
• Rajapakse S, Rodrigo C, Rajapakse A. Atypical manifestations of chikungunya infection. Trans R Soc Trop Med Hyg . 2010;104(2):89–96. doi: 10.1016/j.trstmh.2009.07.031
• Staples JE, Breiman RF, Powers AM. Chikungunya fever: an epidemiological review of a re-emerging infectious disease. Clin Infect Dis . 2009;49(6):942-948. doi: 10.1086/605496
• Lanciotti RS, Kosoy OL, Laven JJ, Panella AJ, Velez JO, Lambert AJ, Campbell GL. Chikungunya virus in US travelers returning from India, 2006. Emerg Infect Dis . 2007;13(5):764–767. doi: 10.3201/eid1305.070015

Chikungunya Virus

Chikungunya virus is primarily spread by mosquitoes. Learn about areas at risk, the illness it causes, and ways to prevent becoming infected, including vaccination.

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

Warner Bros. Discovery Upfront Focuses on Big Franchises Like ‘Harry Potter,’ ‘House of the Dragon,’ ‘The Last of Us’

By Jennifer Maas

Jennifer Maas

TV Business Writer

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Warner Bros. Discovery kept up with TV upfronts week’s biggest trend at their presentation out of The Theater at Madison Square Garden Wednesday: Promoting not just its TV slate as a prime ad-buying opportunity — but also its film franchises.

First up from CEO David Zaslav’s team, WB Discovery revenue and strategy chief Bruce Campbell addressed the Madison Avenue crowd following a sizzle featuring top WBD IP and brands across film and TV series. Then Mindy Kaling took the stage to promote her Max comedy “The Sex Lives of College Girls” before introducing HBO and Max chairman and CEO Casey Bloys.

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And it’s true, Bloys confirmed it himself when he came out and touted the one-year anniversary of Max, the rebranded, combined HBO Max-Discovery+ streaming service. Bloys’ chunk of the show also included new footage and images from “House of the Dragon” Season 2, the upcoming “Dune” prequel series “Dune: Prophecy,” the third season of “The White Lotus” and “The Last of Us” Season 2.

Bloys also brought out “And Just Like That” star Sarah Jessica Parker to talk about the legacy of “Sex and the City’s” Carrie Bradshaw, and “Hacks” stars Hannah Einbinder and Paul W. Downs (who is also co-creator of the Max original) to showcase their comedic chops.

The HBO and Max boss made sure to highlight the power of Warner Bros. films on streaming, noting the draw that “Barbie” and “Wonka” have had on streaming so far, and the anticipation for “Dune 2” to hit Max next week.

U.S. networks chairman and CEO Kathleen Finch got an intro from Adult Swim’s “Rick and Morty,” before coming out to reveal a few bit cable announcements, including news of a “Harry Potter” baking competition at Food Network, the plot of the upcoming “Rick and Morty” anime series, John Cena as host of this year’s “Shark Week” programming at Discovery, and a new HGTV series reuniting “Flip or Flop” stars Tarek El Moussa and Christina Hall post-divorce.

“We are the most powerful creators of unscripted content across platforms and places,” Finch said. “We draw the biggest collective audience in cable, and provide an unparalleled way to reach consumers in a trusted environment. Our shows, franchises and brands continue to deliver value to consumers and advertisers on linear and on Max. Regardless of how or where they watch, viewers come to WBD for our addictive content. Only at WBD could we bring one of the biggest action stars face-to-face with the ocean’s biggest predators as John Cena hosts this year’s Shark Week, and also travel to Hogwarts in an innovative new way.”

Like Bloys, Finch touted how her division is utilizing WB films to woo advertisers, pointing to TNT as the cable home for airings of “The Batman,” “Dune” and “Black Adam.”

Elsewhere in the presentation, CNN boss Mark Thompson revealed his working strategy for the news network’s programming, from the daily news content to original series and films, and the TNT Sports team came out to field a speed round of season predictions.

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Speaking more specifically to WBD’s ad offering, U.S. ad sales chief Jon Steinlauf gave the corporate pitch: “While many streamers have increased their ad loads with some now up to 10 minutes an hour, Max averages less than four minutes — to give you more impact and engagement. Ad-supported Max is showing impressive growth. The subscriber base has doubled over the last two years. Half of our new signups are choosing Max with ads. We now simulcast all TNT and TBS live sports on Max. About 50% of those live sports viewers are without pay TV. Over the last year we’ve seen more excitement for our sponsorships and our ad offerings. Premier brands like Mercedes and Google have sponsored some of our biggest original series. And here there are more opportunities ahead.”

“We’ve enjoyed a successful partnership with the NBA for 40 years, and look forward to another season and reaching an agreement that makes sense for all parties,” Silberwasser said.

Yet to emphasize the importance of the NBA to WBD’s basic cable business, the WBD upfront ended with “Inside the NBA” co-host Shaquille O’Neal chatting with Conan O’Brien. O’Brien ribbed O’Neal about his array of endorsement pacts.

“It’s insane how many endorsements you have,” O’Brien joked. “You can’t possibly know all the endorsements you have. In the time that Shaq’s been out here, he has signed deals with the following products: The Shaq and Decker circular saw. The Shaqbook laptop. The Shake Shack Shaq. Shaq Plaque Attack Dental Floss. Shaq Zodiac tarot cards. Shaq Kerouac On the Road Travel Books. The Cheesecake Shaqtory. Shaq Tac Toe. Shaqamole. That’s a fun game. And finally, Shaq oat milk for the Shaqtose intolerant.”

Michael Schneider contributed to this story.

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