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Transforming Clinical Research to Meet Health Challenges

• 1 Office of the Director, National Institutes of Health, Bethesda, Maryland

The COVID-19 pandemic made “clinical trials” a household phrase, highlighting the critical value of clinical research in creating vaccines and treatments and demonstrating the need for large-scale, well-designed, and rapidly deployed clinical trials to address the public health emergency. As the largest public funder of clinical trials, the National Institutes of Health (NIH) launched a high-level effort to absorb the lessons of the pandemic and to assess and build on ongoing initiatives to improve efficiency, accountability, and transparency in clinical research.

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Wolinetz CD , Tabak LA. Transforming Clinical Research to Meet Health Challenges. JAMA. 2023;329(20):1740–1741. doi:10.1001/jama.2023.3964

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Research articles

Efficacy of psilocybin for treating symptoms of depression, reverse total shoulder replacement versus anatomical total shoulder replacement for osteoarthritis, effect of combination treatment with glp-1 receptor agonists and sglt-2 inhibitors on incidence of cardiovascular and serious renal events, prenatal opioid exposure and risk of neuropsychiatric disorders in children, temporal trends in lifetime risks of atrial fibrillation and its complications, antipsychotic use in people with dementia, predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease, impact of large scale, multicomponent intervention to reduce proton pump inhibitor overuse, esketamine after childbirth for mothers with prenatal depression, glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer, use of progestogens and the risk of intracranial meningioma, delirium and incident dementia in hospital patients, derivation and external validation of a simple risk score for predicting severe acute kidney injury after intravenous cisplatin, quality and safety of artificial intelligence generated health information, large language models and the generation of health disinformation, 25 year trends in cancer incidence and mortality among adults in the uk, cervical pessary versus vaginal progesterone in women with a singleton pregnancy, comparison of prior authorization across insurers, diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis, ultra-processed food exposure and adverse health outcomes, added benefit and revenues of oncology drugs approved by the ema, exposure to air pollution and hospital admission for cardiovascular diseases, short term exposure to low level ambient fine particulate matter and natural cause, cardiovascular, and respiratory morbidity, optimal timing of influenza vaccination in young children, effect of exercise for depression, association of non-alcoholic fatty liver disease with cardiovascular disease and all cause death in patients with type 2 diabetes, duration of cpr and outcomes for adults with in-hospital cardiac arrest, clinical effectiveness of an online physical and mental health rehabilitation programme for post-covid-19 condition, atypia detected during breast screening and subsequent development of cancer, publishers’ and journals’ instructions to authors on use of generative ai in academic and scientific publishing, effectiveness of glp-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes, neurological development in children born moderately or late preterm, invasive breast cancer and breast cancer death after non-screen detected ductal carcinoma in situ, all cause and cause specific mortality in obsessive-compulsive disorder, acute rehabilitation following traumatic anterior shoulder dislocation, perinatal depression and risk of mortality, undisclosed financial conflicts of interest in dsm-5-tr, effect of risk mitigation guidance opioid and stimulant dispensations on mortality and acute care visits, update to living systematic review on sars-cov-2 positivity in offspring and timing of mother-to-child transmission, perinatal depression and its health impact, christmas 2023: common healthcare related instruments subjected to magnetic attraction study, using autoregressive integrated moving average models for time series analysis of observational data, demand for morning after pill following new year holiday, christmas 2023: christmas recipes from the great british bake off, effect of a doctor working during the festive period on population health: experiment using doctor who episodes, christmas 2023: analysis of barbie medical and science career dolls, christmas 2023: effect of chair placement on physicians’ behavior and patients’ satisfaction, management of chronic pain secondary to temporomandibular disorders, christmas 2023: projecting complete redaction of clinical trial protocols, christmas 2023: a drug target for erectile dysfunction to help improve fertility, sexual activity, and wellbeing, christmas 2023: efficacy of cola ingestion for oesophageal food bolus impaction, conservative management versus laparoscopic cholecystectomy in adults with gallstone disease, social media use and health risk behaviours in young people, untreated cervical intraepithelial neoplasia grade 2 and cervical cancer, air pollution deaths attributable to fossil fuels, implementation of a high sensitivity cardiac troponin i assay and risk of myocardial infarction or death at five years, covid-19 vaccine effectiveness against post-covid-19 condition, association between patient-surgeon gender concordance and mortality after surgery, intravascular imaging guided versus coronary angiography guided percutaneous coronary intervention, treatment of lower urinary tract symptoms in men in primary care using a conservative intervention, autism intervention meta-analysis of early childhood studies, effectiveness of the live zoster vaccine during the 10 years following vaccination, effects of a multimodal intervention in primary care to reduce second line antibiotic prescriptions for urinary tract infections in women, pyrotinib versus placebo in combination with trastuzumab and docetaxel in patients with her2 positive metastatic breast cancer, association of dcis size and margin status with risk of developing breast cancer post-treatment, racial differences in low value care among older patients in the us, pharmaceutical industry payments and delivery of low value cancer drugs, rosuvastatin versus atorvastatin in adults with coronary artery disease, clinical effectiveness of septoplasty versus medical management for nasal airways obstruction, ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder, early versus delayed antihypertensive treatment in patients with acute ischaemic stroke, mortality risks associated with floods in 761 communities worldwide, interactive effects of ambient fine particulate matter and ozone on daily mortality in 372 cities, association between changes in carbohydrate intake and long term weight changes, future-case control crossover analysis for adjusting bias in case crossover studies, association between recently raised anticholinergic burden and risk of acute cardiovascular events, suboptimal gestational weight gain and neonatal outcomes in low and middle income countries: individual participant data meta-analysis, efficacy and safety of an inactivated virus-particle vaccine for sars-cov-2, effect of invitation letter in language of origin on screening attendance: randomised controlled trial in breastscreen norway, visits by nurse practitioners and physician assistants in the usa, non-erosive gastro-oesophageal reflux disease and oesophageal adenocarcinoma, venous thromboembolism with use of hormonal contraception and nsaids, food additive emulsifiers and risk of cardiovascular disease, balancing risks and benefits of cannabis use, promoting activity, independence, and stability in early dementia and mild cognitive impairment, effect of home cook interventions for salt reduction in china, cancer mortality after low dose exposure to ionising radiation, effect of a smartphone intervention among university students with unhealthy alcohol use, long term risk of death and readmission after hospital admission with covid-19 among older adults, mortality rates among patients successfully treated for hepatitis c, association between antenatal corticosteroids and risk of serious infection in children, the proportions of term or late preterm births after exposure to early antenatal corticosteroids, and outcomes, safety of ba.4-5 or ba.1 bivalent mrna booster vaccines, comparative effectiveness of booster vaccines among adults aged ≥50 years, third dose vaccine schedules against severe covid-19 during omicron predominance in nordic countries, private equity ownership and impacts on health outcomes, costs, and quality, healthcare disruption due to covid-19 and avoidable hospital admission, educational inequalities in mortality and their mediators among generations across four decades, prevalence and predictors of data and code sharing in the medical and health sciences, follow us on, content links.

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Information

Randomized Controlled Trials

Affiliations.

• 1 Department of Quantitative Health Sciences & Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. Electronic address: [email protected].
• 2 Department of Quantitative Health Sciences & Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.
• 3 Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado-Anschutz Medical Campus, Aurora, CO.
• PMID: 32658656
• PMCID: PMC8176647
• DOI: 10.1016/j.chest.2020.03.013

Randomized controlled trials (RCTs) are considered the highest level of evidence to establish causal associations in clinical research. There are many RCT designs and features that can be selected to address a research hypothesis. Designs of RCTs have become increasingly diverse as new methods have been proposed to evaluate increasingly complex scientific hypotheses. This article reviews the principles and general concepts behind many common RCT designs and introduces newer designs that have been proposed, such as adaptive and cluster randomized trials. A focus on the many choices for randomization within an RCT is described, along with their potential tradeoffs. To illustrate their diversity, examples of RCTs from the literature are provided. Statistical considerations, such as power and type I error rates, are discussed with the intention of providing practical guidance about how to specify study hypotheses that address the scientific question while being statistically appropriate. Finally, the freely available Consolidated Standards of Reporting Trials guidelines and US Food and Drug Administration guidance documents are introduced, along with a set of guidelines one should consider when planning an RCT or reviewing RCTs submitted for publication in peer-reviewed academic journals.

Keywords: biostatistics; clinical trials; randomized controlled trials; study design.

Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Publication types

• Research Support, N.I.H., Extramural
• Guidelines as Topic
• Randomized Controlled Trials as Topic / methods
• Randomized Controlled Trials as Topic / statistics & numerical data*
• Research Design / statistics & numerical data*

Grants and funding

• P30 CA043703/CA/NCI NIH HHS/United States

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Clinical Research Advancements Articles

New Center to Explore the Influence of Sex and Gender on Health Care

Gender-specific medicine considers how human biology differs between men and women and how the diagnosis and treatment of diseases may differ regarding both biological sex and gender-specific lived experience.

Inflammatory Biomarker Associated with Mitochondrial Decline Further Linked to Frailty

Researchers at the Johns Hopkins University School of Medicine have developed a mouse model that successfully mimics the development of frailty as mammals — likely including people — get older.

New Findings Show Mitochondrial DNA Fragments in Blood as Important Biomarkers for Aging and Inflammation

In an eight-year study of more than 600 community-dwelling older adults, Johns Hopkins Medicine researchers say they have further linked levels of cell-free DNA (DNA fragments resulting from cell death) circulating in the blood to chronic ...

New Studies Suggest Social Isolation Is a Risk Factor for Dementia in Older Adults, Point to Ways to Reduce Risk

In two studies using nationally representative data from the National Health and Aging Trends Study gathered on thousands of Americans, researchers from the Johns Hopkins University School of Medicine and Bloomberg School of Public Health ...

Research Focuses on Improving Care for People with Dementia

Adults with dementia are sometimes thought to be homogenous and presumed to use a lot of health care services, especially later in life, says geriatrician Stephanie Nothelle. But two recent studies Nothelle directed suggest that’s not the case.

Johns Hopkins Research Suggests Ways to Improve the Medicare Annual Wellness Visit

A new study from Johns Hopkins researchers offers caution about the limitations of the Medicare Annual Wellness Visit, finding that up to 25% of older adults at risk for falls still were prescribed a medication that is considered high risk for that condition.

Johns Hopkins Researchers Find Close Temporal Relationship Between Cancer and Scleroderma Onset among Patients with Anti-RNA pol3

An interview with Ami Shah, co-director of the Johns Hopkins Scleroderma Center

Family Caregivers Share Both Positive And Challenging Experiences In New Study

An old adage goes something like this: “Growing old is not for the faint of heart.” Perhaps there’s something else about the aging human condition at parity with this wisdom: caregiving is both challenging and rewarding.

Pulse Ox: Vital Tech with a Fatal Flaw

In the early days of the COVID-19 pandemic, Ashraf Fawzy remembers one patient who arrived in the intensive care unit of The Johns Hopkins Hospital, a Black woman with asthma.

Blood Levels of ‘Free Range’ DNA May Signal Early Detection of Dementia and Frailty

In a long-term prospective study of more than 600 older participants, Johns Hopkins Medicine researchers say they have evidence that higher levels of cell-free DNA circulating in the blood may signal increased risk of chronic inflammation ...

Understanding Patient Preferences for Deprescribing Medications

Geriatricians routinely see older adults who are prescribed an overload of medicines that may not benefit them or be aligned with their goals —and that often cause harm including falls, cognitive impairment, hospitalization and death. ...

Sjögren’s Disease: Making the Correct Diagnosis

An Interview with Alan Baer, founding Director of the Jerome L. Greene Sjögren’s Center at Johns Hopkins.

Advances in Precision Medicine for Scleroderma and Myositis

New Johns Hopkins research aims to better predict trajectories of disease and how patients will respond to treatments.

Research Advancements Focus on Biomarkers, Disease Management, COVID-19 and More

Despite the challenges posed by the COVID-19 pandemic, 2020 was an exciting year for researchers in the Johns Hopkins Division of Nephrology. Here are some of the high impact journal articles published by the team’s researchers in 2020.

Inclusion Body Myositis: Learning from Musician Peter Frampton

Frampton’s finger dexterity was not at all what his doctor, rheumatologist Lisa Christopher-Stine, M.D., Director of the Johns Hopkins Myositis Center, expected to find; then again, neither was Frampton himself.

PTLD: Recent Advancements in Long-Haul Lyme Disease Research

Some people get bitten by a deer tick that’s infected with Borrelia burgdorferi, develop a rash, are diagnosed with Lyme disease, take antibiotics, feel better, and get their life back to normal. Others aren’t so lucky. Diagnosed just ...

Racial/Ethnic Disparities in Care for Patients with Failing Kidneys Unchanged for Decade

A new study by Johns Hopkins Medicine, the Johns Hopkins Bloomberg School of Public Health, the Harvard Medical School and the Duke University School of Medicine shows that racial and ethnic disparities in the availability and quality ...

For Blacks with Respiratory Ills, Individual and Neighborhood Poverty Yield Worse Outcomes

Socioeconomic status — for both individuals and the neighborhoods in which they live — can negatively impact the health outcomes for Blacks with chronic obstructive pulmonary disease and other respiratory illnesses.

Molecularly Targeted Therapies for Salivary Gland Cancer

Experts at the Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital use highly specialized hormone therapy to target salivary gland tumors based on genetic characteristics.

When Statins Are Not an Option

Lowering Cholesterol Levels in Patients with Immune-Mediated Necrotizing Myopathy

Autoantibodies Offer Clues to Co-Incidence of Cancer and Scleroderma in Some Patients

The Johns Hopkins Scleroderma Center followed a group of 168 patients with anti-RNA Pol III antibodies for five years, comparing those with and without detectable cancer.

Rapid Response to Immune-Related Adverse Events Improves Patient Care

Published results of a Johns Hopkins pilot study showed 73.5% of physicians in the study said recommendations from an immune-related toxicity (IR-tox) team changed their diagnosis or management of immune-related adverse events.

Favorable Five-Year Survival Reported For Patients With Advanced Cancer Treated With The Immunotherapy Drug Nivolumab

Favorable five-year survival rates from the first multidose clinical trial of the immunotherapy drug nivolumab (anti-PD-1) reported.

Molecular Testing of Serial Blood Specimens from Patients with Early Lyme Disease During Antibiotic Treatment Reveals Changing Borrelia Burgdorferi Genotypes

Johns Hopkins pilot study showed a direct molecular Lyme disease diagnostic test could be used to identify and genotype Borrelia burgdorferi during antibiotic treatment in early Lyme disease patients.

Turning Silenced Cancer Genes Back Into Fighters

Targeting protein known as UHRF1 may shrink tumors by restoring aberrant gene regulation in cancer cells.

Study Shows Experimental Drug Can Encourage Bone Growth in Children with Dwarfism

New study results provide hope for altering bone growth in children and teens with a common form of dwarfism

Out of Many Ovarian Precancerous Lesions, One Becomes Cancer

Some deadly ovarian cancers arise from lesions genetically unrelated to each other

Precision Medicine Symposium Highlights a New Path for Data-Driven Research

A May 30 event will spotlight the current and future role of precision medicine at Johns Hopkins Medicine.

Johns Hopkins Study Suggests Consistent Fasting Blood Glucose May Be As Important As A1C

A Johns Hopkins study suggests people whose blood sugar varies widely over time may be at increased risk for serious health problems.

Deep Machine Learning Can More Accurately Identify Erythema Migrans Rashes in Early Lyme Disease

A new study from Johns Hopkins showed a deep machine learning approach can more accurately identify erythema migrans rashes in early Lyme disease. This could facilitate earlier and more accurate diagnoses, earlier and more effective treatments, ...

Unraveling Causes and Finding Treatments for COPD

News and Publications January 14, 2019

Big Data Helps Shape A New Model for Live Kidney Donation

A tool developed by Morgan Grams, MD, PhD, screens potential kidney donor candidates by estimating their own chance of developing kidney disease, and it has been widely adopted by renal specialists around the globe.

Optimizing Outcomes for Type 2 Diabetes with Research and Education

News & Publications January 9, 2019

PET Imaging of Glial Activation in Patients with Post Treatment Lyme Disease

This study uses a neuroimaging radiotracer with positron emission tomography (PET) to quantify cerebral glial activation in brains of patients with post-treatment Lyme disease. Results show elevated central nervous system immune activation ...

For Type 1 Diabetes: The End of Insulin?

News Release December 19, 2018

Cancer Patients Blindsided by Treatment-Induced Inflammatory Arthritis

News Release December 13, 2018

Johns Hopkins Researchers Advance Role of Circulating Tumor DNA to Detect Early Melanoma Growth, Uncover Treatment Options

News & Publications November 26, 2018

Preventing Neonatal Infection: Researchers Improve Long-Term Outcomes for Preemies

Infection prevention efforts are paramount in hospitals, especially in neonatal intensive care units.

Starting Early to Save Lives Later

November 2018

New Directions in Preventing Neonatal Dysbiosis

Necrotizing enterocolitis is one of the leading causes of death in infants.

Spread of Deadly Eye Cancer Halted in Cells and Animals

News and Publications November 12, 2018

Hopkins Model for Glucose Management Reduces Complications, Improves Patient Outcomes

An observation that cardiac surgery patients at The Johns Hopkins Hospital who had diabetes appeared to have longer lengths of stay launched the Inpatient Diabetes Management Service.

Gender Differences in Psoriatic Arthritis

In a recent study, Johns Hopkins researchers and colleagues show that women patients with psoriatic arthritis have worse patient-reported outcomes.

Improving Outcomes for Critically Ill Patients

Dale Needham and colleagues investigate a novel combination of exercise and protein supplementation for patients early during ICU treatment.

A Multidisciplinary Team Takes On Nontuberculous Myobacterial Lung Disease

Nontuberculous mycobacteria, or NTM, is now the dominant mycobacterial disease in the U.S., although the infections are not generally thought to pass from person to person. Image shows 3D rendering of NTM.

Road to Cell Death More Clearly Identified for Parkinson’s Disease

November 2, 2018

Study at Johns Hopkins Hospital Leads To Changes in Reporting Patient Safety Concerns

September 20, 2018

Johns Hopkins Kimmel Cancer Center Researchers Using Big Data to Predict Immunotherapy Responses

Cancer researchers are discovering new ways to monitor the effectiveness of immunotherapy treatments

Turning Off Protein Could Boost Immunotherapy Effectiveness on Cancer Tumors

News & Publications - July 31, 2018

Computer Algorithm Maps Cancer Resistance to Drugs, Therapy

Common Diabetes Drug Found Safe for Most Diabetics with Kidney Disease

Kidney Disease Expert Wins University's Frontier Award

News Release January 2017

Confronting Disparities in Kidney Disease

Research Update February 2018

A Novel Way to Heal Diabetic Wounds in Older Adults

News Release December 1, 2017

The (Remote) Eye Doctor Will See You Now

The ophthalmology telemedicine program is saving patients considerable time and stress.

Three Approaches to Precision Medicine for Improved Patient Care

INSIGHT November/December 2017

Testing a More Streamlined Way to Screen Patients?

INSIGHT November 7, 2017

App to Make Medication Compliance for Opioid Addiction Easier

Johns Hopkins Startup Developing At-Home Rehabilitation Game

INSIGHT August 28, 2017

Artifact App Improves Accuracy of Patient Data in Medical Records

The app is available on mobile, tablet or desktop, so providers can answer questions on the go.

Virtual Reality System Helps People with Low Vision

Hopkins Medicine Spring / Summer 2017

New Device Aims to Reduce Kidney Injuries from Cardiac Surgery

INSIGHT July 2017

Handheld Device for Early Warning of Heart Failure

INSIGHT July 3, 2017

Immunotherapy Treatments Bring Success

Dome July/August 2017

Better Treatment for Aggressive Prostate Cancer

OnTarget 2017/2018

Quickly Assessing Brain Bleeding in Head Injuries Using New Device

Recent News April 5, 2017

Anatomy App Offers Interactive Learning from Johns Hopkins Expert

BestPractice March 24, 2017

Tapping into Psilocybin’s Potential

Recent News March 21, 2017

Incorporating Immunotherapy into the Standard of Care

Recent News March 14, 2017

Technology Licensed from Johns Hopkins Sends Texts to Track Moods

Insight October 31, 2016

Johns Hopkins-Derived Drug Could Transform Heart Failure Treatment

A Virtual Space for Children with Liver Disease and Their Families

Bandages with Pressure Sensors Could Prevent Bedsores

InsightSeptember 28, 2016

Web Application Predicts Status of Low-Risk Prostate Cancer

Insight September 28, 2016

Life and Death: Hopkins Team Finds Hospital Readmissions Sometimes Save Lives

Safety Insider September 1, 2016

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Focus on Research, Clinical Trials

A talk with dr. patricia lorusso: 2024-25 president of the american association of cancer research, inspired by patients.

This article was published recently in Breakthroughs, the magazine of Yale Cancer Center and Smilow Cancer Hospital

The halls of Yale Cancer Center rarely ring with anything other than footsteps, hurried hellos, and the occasional polite mention that a meeting has let out and there are leftover bagels in the kitchenette. The action takes place in 16 Smilow Cancer hospital locations, the labs, and the research programs.

But on some days, Patricia M. LoRusso, DO, PhD(h), professor of Medicine (Medical Oncology), Yale School of Medicine, chief of the Early Therapeutics Program, and Associate Cancer Center Director for Experimental Therapeutics is in her YCC office and she brings a unique energy.

“Hey, how you doing? Yeah, it’s been a while,” Dr. LoRusso says, smiling into her phone. She is behind her office desk with the door open, but it is as if she is beside whomever is on the other end of the phone. “Hey listen, I’m calling about…yeah, that trial. Is there any way we can fit one more? I’ve got this patient, just saw her today….”

Dr. LoRusso’s heart is always in clinic. And when she’s not physically there, it seems she’s talking about clinic, or bargaining to improve patient support in clinical trials, or advising why there should be more or greater access to clinical trials.

Clinical trials are among the critical final steps in bringing a new treatment to patients with cancer and they typically follow years of earlier research, modeling using mice, other preclinical model systems and published findings. Successful clinical trials with patients are necessary to obtain federal approval for a treatment’s wider user. Dr. LoRusso’s message about the importance of clinical trials is similar whether she’s talking to a patient or is in an advisory meeting at the White House, as she was a few months ago, or part of a panel at the annual "People v. Cancer" symposium hosted by the national magazine, The Atlantic .

“Less than 3% of [cancer] patients are going on clinical trials and the numbers are declining,” Dr. LoRusso told The Atlantic audience in November.

As potential drug treatments become increasingly focused, the need for more trials is critical and they need to include more diverse patients. “There was a publication last year in JAMA that showed that up to 40% of clinical trials had no underrepresented patients. It’s important to have representation of these populations because we have to understand, before these drugs become FDA-approved for commercial use, how these drugs are going to act in all patients” in terms of benefits and toxicities.

An internationally recognized expert in drug development and early-phase clinical investigation of novel therapies, Dr. LoRusso has always done clinical research.

At present, YCC has 26 actively enrolling phase 1 trials, and Dr. LoRusso and team are working to increase accessibility and participation. The intent is to improve education tools, including “myth busting” messaging about trials on monitors in Smilow clinics; continued coordination with Community Engagement and Health Equity (the COE program at YCC); and less cumbersome informed consent forms. In addition to recruiting additional faculty, as the early phase program is growing along with the excitement in the novel drug therapy landscape, Dr. LoRusso hopes to recruit 250 patients to early phase trials of novel therapies in 2024 and to expand efforts beyond the Smilow site in Bridgeport/Trumbull.

It’s a heavy lift for 2024 given that, in April, Dr. LoRusso became president of AACR—the American Association of Cancer Research—the largest cancer research program internationally, with a membership of 58,000. But the pull of her patients will remain.

“I love what I do,” she said. “It humbles you. It makes one realize how blessed we are to be healthy, and how very much of a hero each of patients are, for helping to advance new treatments.

“You’ve got to remember that the patients, for the most part, have advanced disease…many of them have no other options. They are the heroes. They are giving so much time, of what little time that they have left. They go on trials in the hopes that they respond to the new therapies, often having failed all standard drugs that are typically given to patients with their disease. They are hoping that participation will allow them to live longer, but they also are helping develop new drugs for mankind,” Dr. LoRusso said.

Dr. LoRusso uses the word “phenomenal” to describe the leap forward in cancer research enabled by the groundbreaking work on the human genome, new lab technologies and computational advancements. The drugs being developed are more selective for specific targets and tumor types, meaning they benefit thinner slices of the cancer patient population, but bring the potential for more targeted treatment and hopefully all this translates to a greater response and a longer life.

As for the always hopeful prediction that a cancer cure is closer every day, Dr. LoRusso allows that “We know a lot, but I don’t think we are there. We are closer, but we’re not on the cusp — we have quite a long way to go.”

“As we become more knowledgeable, we realize the many different faces and diseases of cancer. Each patient, even with a similar diagnosis, has a different disease. We are not at the level of personalization yet that I think we need to be to have the greatest impact,” she said.

“That’s going to come with more translational research, more bedside to bench research, more clinical research in terms of novel treatments, designs and approaches to giving drugs—which I think is hopefully going to translate to better individualized therapies for patients,” she said, emphasizing the importance of the process being bi-directional—from lab bench to clinical bedside and then back to the bench.

Still, Dr. LoRusso is quick to note the impressive advances and she’s seen many since she began. Her career in cancer research can be described as beginning before she even graduated high school. That was when she lost both parents to cancer in her youth.

“I always look at cancer as my enemy. It’s been my enemy for many, many years. When my parents were sick, there were no drugs,” she told an AACR interviewer in a video produced in 2022. The video was made when she won the prestigious Joseph H. Burchenal Award for Outstanding Achievement in Clinical Cancer Research.

“For clinical research, your greatest resource is the patients — the most precious, valuable resource.”

So, while the quest for cures continues, breakthrough treatments that sabotage or frustrate cancer’s return or its growth still translate to lives saved and years lived. “That’s the fuel that has kept me going,” Dr. LoRusso said.

Featured in this article

• Patricia LoRusso, DO Amy and Joseph Perella Professor of Medicine (Medical Oncology); Chief, Experimental Therapeutics; Associate Cancer Center Director, Experimental Therapeutics

Prioritizing Health | ACC.24 Research in the Consumer News

May 03, 2024

Cardiology Magazine

Research from ACC.24 also finds its way to patients and the general public. Here's a roundup of some of these key studies making headlines in major news outlets.

E-Cigarette Use Increases HF Risk: A 19% higher risk of developing heart failure (HF) was found among users of e-cigarettes, vs. nonusers in a prospective observational study. Over the median 45-month follow-up, 3,242 of 175,667 participants (average age 52 years, 60.5% women) developed HF. The increased risk was statistically significant for HF with preserved ejection fraction (HFpEF) but not for HF with reduced ejection fraction (HFrEF). "I think this research is long overdue, especially considering how much e-cigarettes have gained traction," said lead author Yakubu Bene-Alhasan, MD . Surveys indicate about 5% to 10% of U.S. teens and adults use e-cigarettes.

More Greenspace, Better Heart Health: People living in areas with more sidewalks were 9% less likely to suffer a major adverse cardiovascular event than those who did not, and participants living in neighborhoods with vertical green space – trees and clear sky – were 5% less likely, over a 27-month follow-up. The study authors found no significant association with horizontal greenspace (grass). "A lot of research has shown that environmental factors strongly affect our health," said lead author Zhuo Chen, PhD. "If we can find a way to stratify this risk and provide interventions before cardiovascular events happen, then we could save a lot of lives."

Eggs and CVD Risk: At four months, no difference was found in cholesterol levels between participants who ate ≥12 fortified eggs per week and those who ate fewer than two eggs, in a prospective, randomized, study with 140 patients (≥50 years, average age 66 years, 50% women, 27% Black) who had either experienced one cardiovascular event or had two cardiovascular risk factors. The 0.64 mg/dL reduction in HDL-C and 3.14 mg/dL in LDL-C found in the fortified egg group was not significant compared with the non-egg group. "While this is a neutral study, we did not observe adverse effects on biomarkers of cardiovascular health and there were signals of potential benefits of eating fortified eggs that warrant further investigation in larger studies as they are more hypothesis generating here," said Nina Nouhravesh, MD, the study's lead author.

Nearby AEDs Rarely Used: AEDs are more readily available in public spaces, but their use for an out-of-hospital cardiac arrest (OHCA) was low in a study of 1,799 cases in Kansas City, MO, between 2019-2022 using data from a national registry. An AED was within a four-minute walk for half of the 270 cases that occurred in public but was used in only 13 cases; bystander CPR was given in only 42%. Of the OHCA cases that occurred at home, an AED was within a four-minute walk for a quarter of them, but was not used for any, and CPR was given in 42% of cases. Mirza S. Khan, MD, et al., noted identifying this gap could help with ongoing efforts to improve signage around AEDs, provide apps or mapping tools to help people locate them and increase education and awareness through community volunteer training programs.

High Stress and Genetics Increase ACS Risk: People with a high genetic stress sensitivity have a higher risk of acute coronary syndromes (ACS) in response to stressful cultural or political events, such as Christmas, presidential elections and major sporting events, by as much as 34%, identifying a new risk factor for screening.

ADHD Stimulants and Heart Damage: Young adults prescribed stimulant medications for attention-deficit/hyperactivity disorder (ADHD), compared with those who were not, were 17% more likely to have cardiomyopathy at one year and 57% more likely at eight years. After 10 years, only 0.72% and 0.53% of patients developed cardiomyopathy, respectively. Pauline Gerard, the lead author said, the risk is real but small.

Anxiety, Depression and CV Risk in Younger Women: Screening for cardiovascular risk factors should start at a younger age in women with a history of anxiety or depression, which was found to be associated with a near doubling in risk of developing high blood pressure, high cholesterol or diabetes over a 10-year period in those <50 years compared with women without either condition, putting them on par for risk with men the same age.

Higher CAC Levels in Post Menopausal Women: More data highlight the increased risk in women after menopause, with a study showing a rise in coronary artery calcium (CAC) among those taking a statin. Between two scans taken a year apart, there was a median 8-point rise in CAC among women with a baseline CAC of 1-99, twice the median seen in men, and a median 31-point rise in those with a baseline CAC of 100-399, nearly double the rise seen in men.

Sleep, Alcohol, Sodium: Looking at modifiable risk factors, three different studies provide concrete steps for reducing risk. One, get more sleep. Less than seven hours a night was associated with a 7% higher risk of developing hypertension, and this spiked to 11% for those sleeping less than five hours. Two, drink less alcohol. Young and middle-aged women who drink eight or more alcoholic drinks a week had a 45% higher risk of cardiovascular disease vs. those with a low intake and 29% higher vs. those with a moderate intake. Binge drinking was associated with a 68% increased risk. Three, eat less sodium. A new study found that 89% of participants with cardiovascular disease eat double the recommended daily maximum intake of 1,500 mg, consuming an average of 3,096 mg sodium.

Click here to read the full news story for more detailed results.

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Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Hypertension, Sleep Apnea

Keywords: Cardiology Magazine, ACC Publications, Heart Injuries, Heart Disease Risk Factors, Cardiomyopathies, Hypertension, Sleep, ACC Annual Scientific Session, ACC24

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Environmental Factor

Your online source for niehs news, niehs-supported research can help people with asthma breathe better.

Recent scientific advances help to identify root causes of and new treatment approaches for asthma, a chronic respiratory disease.

By Janelle Weaver and Caroline Stetler

In recognition of Asthma Awareness Month, Environmental Factor shares the latest discoveries made by NIEHS scientists and grant recipients related to the chronic respiratory disease.

Asthma, which is characterized by coughing, wheezing, chest tightness, and shortness of breath, affects about 25 million people in the United States, including 4.7 million children and adolescents. In 2021, more than 3,500 people across the country died from asthma-related causes.

The following examples of recently published research aim to improve the diagnosis, treatment, and prevention of asthma by better understanding the environment’s role in the disease.

Majority of clinicians do not frequently assess environmental asthma triggers

Environmental assessment and recommendations to patients vary considerably among asthma care providers, according to NIEHS researchers and their collaborators. A higher percentage of specialists assessed asthma triggers at home, school, or work than primary care or advanced practice providers. However, 46%-76% of clinicians, depending on clinician type, reported not assessing triggers almost always during asthma visits. Read the full summary .

Citation : Salo PM, Akinbami LJ, Cloutier MM, Wilkerson JC, Elward KS, Mazurek JM, Diette GB, Mitchell TA, Williams S, Zeldin DC. 2023. Environmental management of asthma in clinical practice: results from the 2012 National Ambulatory Medical Care Survey . J Allergy Clin Immunol Glob 3(1):100192.

Plasma proteomic signatures of adult asthma

A large-scale proteomics study identified more than 100 plasma proteins associated with asthma in adults, according to NIEHS researchers and their collaborators. In addition to validating previous associations, the researchers identified many novel proteins that could inform the development of diagnostic biomarkers and therapeutic targets in asthma management. Read the full summary .

Citation : Smilnak GJ, Lee Y, Chattopadhyay A, Wyss AB, White JD, Sikdar S, Jin J, Grant AJ, Motsinger-Reif AA, Li JL, Lee M, Yu B, London SJ. 2024. Plasma protein signatures of adult asthma . Allergy 79(3):643-655.

Targeting the root cause of asthma

Housing policy may be a tool to reduce childhood asthma disparities, according to recent findings from the NIEHS-funded Mobility Asthma Project . As reported in the Journal of the American Medical Association, children who move to neighborhoods with lower rates of poverty experience significant improvements in asthma symptoms, in part by reducing stress. Read the full article .

Citation : Pollack CE, Roberts LC, Peng RD, Cimbolic P, Judy D, Balcer-Whaley S, Grant T, Rule A, Deluca S, Davis MF, Wright RJ, Keet CA, Matsui EC. 2023. Association of a housing mobility program with childhood asthma symptoms and exacerbations . JAMA 329(19):1671-1681.

Why anti-thromboxane therapies have failed in asthma clinical trials

Thromboxane A2 (TXA2) can dampen the immune response in the allergic lung, which may have important therapeutic consequences, according to NIEHS researchers and their collaborators. In contrast to its acute, pro-inflammatory, and bronchoconstrictive effects, TXA2 also has longer-lasting immunosuppressive effects that attenuate Th2 and Th9 cell differentiation that drives asthma progression. These results help explain the failure of anti-thromboxane therapies and suggest that targeting the TXA2/TP receptor signaling pathway may lead to the development of novel asthma treatments. Read the full summary .

Citation : Li H, Bradbury JA, Edin ML, Gruzdev A, Li H, Graves JP, DeGraff LM, Lih FB, Feng C, Wolf ER, Bortner CD, London SJ, Sparks MA, Coffman TM, Zeldin DC. 2024. TXA2 attenuates allergic lung inflammation through regulation of Th2, Th9 and Treg differentiation . J Clin Invest e165689 [Online 14 Mar 2024].

Community-level characteristics modify childhood asthma risk

Early-life air pollution exposure is associated with increased childhood asthma incidence, with higher risk among minoritized families living in densely populated communities, according to NIEHS-funded researchers. Their results suggest that exposure to fine particulate matter (PM) smaller than 2.5 microns in diameter (PM2.5) and nitrogen dioxide (NO2) may play a role in the development of asthma by early and middle childhood in communities characterized by fewer opportunities and resources and multiple environmental exposures. Read the full article .

Citation : Zanobetti A, Ryan PH, Coull BA, Luttmann-Gibson H, Datta S, Blossom J, Brokamp C, Lothrop N, Miller RL, Beamer PI, Visness CM, Andrews H, Bacharier LB, Hartert T, Johnson CC, Ownby DR, Khurana Hershey GK, Joseph CLM, Mendonça EA, Jackson DJ, Zoratti EM, Wright AL, Martinez FD, Seroogy CM, Ramratnam SK, Calatroni A, Gern JE, Gold DR; ECHO Children’s Respiratory and Environmental Workgroup. 2024. Early-Life exposure to air pollution and childhood asthma cumulative incidence in the ECHO CREW Consortium . JAMA Netw Open 7(2):e240535.

Additional resources to explore

• For resources on the prevention, treatment, and management of asthma, check out the NIH Learn More Breathe Better® program .
• Lower allergen levels in your home by reviewing these tips on the NIEHS asthma webpage .
• Join an asthma study to help scientists understand how bacteria and other factors in the environment affect people who have moderate to severe asthma.
• Learn about new research exploring the asthma-air pollution connection .
• Check out the asthma research portal from the National Institute of Allergy and Infectious Diseases.

(Janelle Weaver, Ph.D., is a contract writer for the NIEHS Office of Communications and Public Liaison. Caroline Stetler is Editor-in-Chief of the Environmental Factor, produced monthly by the NIEHS Office of Communications and Public Liaison.)

Related Articles

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Ask the Expert: How does NIEHS research on PFAS affect me?

Community engagement critical to addressing women’s health concerns

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City of Hope to Present New Research at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024

Published: May 02, 2024

Additional data spotlight clinical oncology therapies for cancers of the colon and rectum, kidney, and breast

LOS ANGELES--( BUSINESS WIRE )-- World-renowned physicians and researchers from City of Hope ® , one of the largest cancer research and treatment organizations in the United States, will present new findings and offer expert perspectives on leading-edge cancer research and treatment development at the ASCO Annual Meeting 2024, which will take place in Chicago from May 31 to June 4.

In total, City of Hope experts will present at 64 sessions, including oral abstracts, rapid oral abstracts, clinical science symposiums and education sessions.

ORAL AND RAPID ORAL ABSTRACT SESSIONS

• “ Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator’s choice of therapy for KRAS G12C-mutated metastatic colorectal cancer (mCRC) ” Session LBA 3510 presenting Monday, June 3, from 1:21 to 1:27 p.m. CT Session title: Gastrointestinal Cancer—Colorectal and Anal Presenter: Marwan G. Fakih , M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research
• “ Post-transplant cyclophosphamide-based graft-versus-host disease prophylaxis following mismatched unrelated donor peripheral blood stem cell (PBSC) transplantation ” Session 6503 presenting on Friday, May 31, from 3:45 to 3:57 p.m. CT Session title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Presenter: Monzr M. Al Malki , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation
• “ Glofitamab monotherapy in patients with heavily pretreated relapsed/refractory (R/R) mantle cell lymphoma (MCL): Updated analysis from a phase I/II study ” Session 7008 presenting on Saturday, June 1, from 5:24 to 5:36 p.m. CT Session title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Presenter: Tycel Phillips , M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation
• “ Preliminary safety, pharmacokinetics and clinical activity of DFF332, an oral HIF2α inhibitor, as monotherapy in a phase 1 dose escalation study in patients with advanced clear cell renal cell carcinoma ” Session 4513 presenting Saturday, June 1, from 8:30 to 8:36 a.m. CT Session title: Genitourinary Cancer—Kidney and Bladder Presenter: Sumanta Kumar Pal , M.D., FASCO, City of Hope professor, Department of Medical Oncology & Therapeutics Research

CLINICAL SCIENCE SYMPOSIUMS

• “ Geriatric assessment-directed supportive care intervention (GAIN-S)-implementation via telehealth in a lower-resourced community ” Session 1510 presenting Saturday, June 1, from 1:39 to 1:51 p.m. CT Session title: Patient-Centered Care for Older Adults With Cancer Presenter: Tanyanika Phillips , M.D., M.P.H., City of Hope assistant clinical professor, Department of Medical Oncology & Therapeutics Research Senior author: William Dale , M.D., Ph.D., FASCO, City of Hope professor, Department of Supportive Care Medicine
• “ Quality of life for older patients with metastatic cancer in Brazil: A telehealth-based geriatric assessment and supportive care intervention (GAIN-S) ” Session 1514 presenting Sunday, June 2, from 11:54 a.m. to 12:06 p.m. CT Presenter: Cristiane Decat Bergerot, Ph.D. Senior author: William Dale , M.D., Ph.D., FASCO, City of Hope professor, Department of Supportive Care Medicine

POSTER ABSTRACT SESSION

• “ A phase I/II trial of palbociclib, pembrolizumab, and endocrine therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer (MBC): Clinical outcomes and stool microbial profiling ”* Session 1038 on Sunday, June 2, from 9 a.m. to noon CT Session Title: Breast Cancer—Metastatic Presenter: Alexis LeVee , M.D., City of Hope Hematology & Medical Oncology Chief Fellow * Conquer Cancer, the ASCO Foundation, awarded LeVee a 2024 ASCO Annual Meeting Merit Award , which supports students and trainees who are first authors on abstracts selected for presentation.

At the meeting, ASCO will recognize researchers who have reshaped cancer care. City of Hope’s William Dale , M.D., Ph.D., FASCO, is the recipient of this year’s B.J. Kennedy Geriatric Oncology Award, which honors geriatric oncologists who have demonstrated outstanding leadership and achievement in the field of geriatric oncology. Dale is the first non-oncologist recipient in the history of the award. Of note, Dale is first author of ASCO’s recent cancer and aging guideline update .

• Online on-demand award lecture on Friday, May 31, from 1 to 1:45 p.m. CT Presenter: William Dale , the George Tsai Family Chair in Geriatric Oncology and vice chair for academic affairs in the Department of Supportive Care Medicine at City of Hope

EDUCATION SESSIONS

• “Evidence Evaluating Cannabis’ Efficacy Across the Cancer Care Continuum” Monday, June 3, from 8:30 to 8:45 a.m. CT Session title: Evidence-Based Integrative Oncology: Guideline Insights for Comprehensive Care Presenter: Richard T. Lee , M.D., FASCO, City of Hope clinical professor, Supportive and Integrative Medicine Program; Cherng Family Director's Chair for the Center for Integrative Oncology
• “Tissue-Based Molecular Testing and the Role of Artificial Intelligence” Monday, June 3, from 10 to 10:15 a.m. CT Session title: Should I Order the Test? Expanding the Array of Emerging Diagnostics in Breast Cancer Presenter: Daniel Schmolze , M.D., City of Hope associate clinical professor, Department of Pathology
• “What Is Variant Histology Renal Cell Cancer and What Are the Available Treatment Options?” Monday, June 3, from 3:15 to 3:30 p.m. CT Session title: Managing Variant Histologies in Urothelial and Renal Cell Cancers Presenter: Sumanta Kumar Pal , M.D., FASCO, City of Hope professor, Department of Medical Oncology & Therapeutics Research

About City of Hope

City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope TM . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn .

View source version on businesswire.com: https://www.businesswire.com/news/home/20240502446722/en/

Zen Logsdon 626-409-9367 [email protected]

Source: City of Hope

View this news release online at: http://www.businesswire.com/news/home/20240502446722/en

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What marijuana reclassification could mean for health treatments

The federal government is poised to remove marijuana from the most dangerous class of drugs, which could open up more clinical treatments and research opportunities.

The Justice Department is recommending reclassifying marijuana  as a Schedule III drug, down from a Schedule I drug. Its proposal, which would need to be cleared by the White House Office of Management and Budget, could allow researchers to investigate marijuana’s clinical applications more broadly.

Related: Federal addiction treatment dollars off-limits for marijuana

Still, many questions remain as to how marijuana would be used, how open providers and patients would be to marijuana as a medical treatment, and what coverage and payment for such treatments would look like.

Here’s what to know about how marijuana could be used in the clinical setting.

What are Schedule I drugs?

Schedule I drugs, including marijuana, heroin, psilocybin and ecstasy, have the most regulatory restrictions on research, supply and access since the Drug Enforcement Administration deems them high risk and without currently accepted medical use.

That means the Health and Human Services Department, the Food and Drug Administration and DEA must approve researchers' marijuana-related studies, posing a significant barrier to entry. Only the University of Mississippi farm has federal approval to grow marijuana, and only some strains and potency levels.

Even so, the limited research on marijuana and psilocybin has shown that they can be used to treat post-traumatic stress disorder and depression, among other ailments .

Will marijuana be used more widely?

More than 8.3 million people reported using doctor-prescribed marijuana in 2020, according to a 2023 study published in the American Journal of Preventative Medicine. While that number is expected to increase if the federal government reclassifies marijuana, it's unclear what use of the drug will look like in the clinical setting.

Even in more traditional drug approvals, it tends to take time for treatments to be widely accepted by providers and patients.

“The widespread adoption of marijuana-based treatments in clinical settings would likely be a gradual process that depends on the accumulation of evidence, regulatory decisions and shifts in professional and public perceptions,” said Tony Yang, a health policy professor at George Washington University.

Take biosimilars , which are less expensive copies of biologic drugs made from living organisms, as an example. While the Food and Drug Administration has approved around 50 biosimilars since 2015, biosimilar use has been relatively slow as patients and providers become more familiar with the products and the regulatory approval process.

For instance, certain biosimilars used as immunosuppressants, as synthetic forms of insulin and to stimulate white and red blood cell production only gained 23% market share three years after they hit the market, according to a first-quarter market report from Samsung Bioepis.

Who would pay for marijuana?

Providers' clinical use of marijuana may also hinge on reimbursement.

Lingering questions remain on whether health insurance plans and payers, including Medicare and Medicaid, would cover medical marijuana prescriptions, as well as what copayments would be implemented, Yang said. Other questions include whether physicians would be reimbursed for medical marijuana-related patient evaluations and follow-up visits, how dispensaries would be reimbursed and if payment policies would be affected by discrepancies between state and federal laws, he said.

Medicare and some insurers already cover Epidiolex , an epilepsy drug made from marijuana.

There is a growing set of venture capital funds for psychedelic, ketamine and marijuana-derived drugs that may provide funding for research, said Cody Powers, a principal at the consultancy ZS, which focuses on pharmaceuticals.

"I would expect those funds to initiate fundraising off of this development at some point," he said.

Several insurance companies and associations that represent insurers declined to comment, but some insurers argued in a recent court case that federal law prevents them from paying for marijuana. Even if marijuana is reclassified, Schedule III drugs are still illegal under federal law.

Medical marijuana patients and a marijuana dispensary in New Mexico filed the lawsuit in state court in 2022 against several insurers, alleging they should pay for marijuana used to treat mental health. The pending lawsuit has since been transferred to a New Mexico federal court.

How could reclassifying marijuana affect healthcare research?

Reclassifying marijuana would make it easier for researchers to access and study marijuana.

To study Schedule I drugs, research institutions must thoroughly document how they plan to distribute, receive and track the drugs, Powers said. The regulations are much easier to meet for Schedule III drugs, likely leading to more studies, as long as there’s demand from drugmakers and providers, he said.

Schedule III drugs have a low risk for of abuse and have some medical value, according to the DEA. Under that classification, academics and scientists would have more flexibility to study different marijuana strains, extracts and formulations, Yang said.

“With the reduced regulatory barriers, the reclassification could pave the way for more clinical trials to evaluate the efficacy of marijuana-based treatments for various medical conditions,” he said.

Several academic health systems and provider associations declined to comment on how reclassifying marijuana could impact research.

At some point, research findings will pave the way for FDA approval, said Monica Hon, vice president at the healthcare consultancy Advis.

"To be recognized as a viable choice for treatment would legitimize marijuana at a national level," she said.

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