Announcements

Clinical Trials are research studies involving human volunteers to evaluate medical products and participants in clinical trials should represent the patients that will use the medical products” (Clinical Trial Diversity | FDA). Historically, due to medical mistrust, trial availability, access and eligibility barriers, people from racial and ethnic minority and other diverse groups (due to comorbidity, organ dysfunction, etc.) are underrepresented in clinical trials. The lack of information on the efficacy and safety of a new treatment in such patient population often leads to suboptimal management of patients in the clinical practice.

Over the past few years, FDA has issued various guidance to encourage enrollment of diverse population in the clinical trial. In April 2022, FDA issued a news release: “FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials” and established Clinical Trial Diversity | FDA. Concurrently FDA released draft guidance on improving enrollment of underrepresented populations in clinical trials.

In this seminar, you will hear from two experts leading the research in the space, and we dive deep to understand the why and how to enroll and improve clinical trial diversity.

Title and Abstract of Presentations

Improving Clinical Trial Diversity Mark Rothmann, Ph. D.Director, Division of Biometrics II,U. S. Food and Drug Administration

ABSTRACT：

FDA recently issued a new draft guidance for industry promoting enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved. Enrolling participants with a wide range of characteristics allows for an assessment of the impact of those characteristics on the safety and effectiveness of the study drug.FDA is working on revising related guidances and has multiple projects on assessing representation of underrepresented groups. We have held a workshop and symposium in recent years on heterogeneous treatment effects with the workshop concentrated on statistical approaches. CDER has published Drug Trials Snapshots and annual reports beginning in 2015 which provide the distributions of demographic subgroups and other important subgroups that participate in those clinical trials that lead to the initial approval of the drug/therapeutic biologic along with subgroup analysis.

Improving Diversity in Clinical Trials Jie Chen, PhDTaimei Technology & Overland Pharmaceuticals Joint work withYing Lu, PhD (Stanford) andShivaani Kummar, MD (Oregon Health & Science University)

ABSTRACT：

Enrolling subjects from diverse backgrounds to participate in clinical trials is critical not only for promoting health equity, but also for evaluating medical products among those who would likely use these products upon regulatory approval. However, data demonstrates that subjects with certain demographic (e.g., race, ethnicity) and non-demographic (e.g., comorbidity, organ dysfunction) characteristics are underrepresented in clinical trials. In this talk we will first review the current status of clinical trial participation and then outline the challenges to improving diversity in clinical trial participation. These challenges will be discussed from patient, physician, healthcare system, and some trial-related perspectives. We propose some strategies such as modifiable trial design for rolling enrollment, pragmatic clinical trials, use of real-world data and real-world evidence in trial design and conduct, digital healthcare technologies and decentralized clinical trials, and supportive services to improve clinical trial diversity.