By Surabhi Dangi-Garimella, PhD
Diversity presents facts. Diversity provides a true reflection of reality, and this holds true for clinical trials as well. The FDA’s Office of Minority Health and Health Equity is a big proponent of diversity among clinical trial participants to advance health equity. Several bills are currently being deliberated on by lawmakers on increasing diversity in clinical trials, but drug manufacturers seem reluctant.
The FDA’s Position
Underrepresentation of racial and ethnic minorities and certain other demographic groups (geriatric/pediatric) in clinical trials means we cannot generalize a drug’s efficacy or toxicity, which can vary based on a person’s age, race, and ethnic background. If trials restrict eligibility and don’t represent the diversity in the community, real-word results could spring surprises once the drug is launched.
Statistics show that while minority communities (racial and ethnic) make up nearly 40% of the U.S. population, an overwhelming 75% of the 32,000 clinical trial participants for 53 new drugs approved in 2020 were white. Further,
- Only 8% were black or African American
- 11% were Hispanic
- 6% were Asian
- 30% were over 65 years old
Knowing that a higher number of chronic disease patients belong to minority subgroups, this underrepresentation could hurt. The reasons behind lack of diversity in the trial scenario are many—stringent eligibility criteria for participation are just one of them. Other factors include:
- Access to information on clinical trials
- Access to clinical trials
- Mistrust in the medical system
- Negative beliefs and attitudes
A concerted effort from all stakeholders involved—healthcare providers, community partners, the pharmaceutical industry, and policy makers—is crucial to alter this scenario. The FDA recently released a draft guidance for drug manufacturers that urges them to develop a Race and Ethnicity Diversity Plan early on in their clinical study that is based on the guidance.
During his testimony before the House Energy & Commerce Subcommittee on Health, Ruben Mesa, MD, Director of UT Health San Antonio MD Anderson Cancer Center, said, “As America becomes more racially and ethnically diverse, a clinical trial system that fails to enroll patients from growing demographics will not support the pace of innovation that will help us meet our potential.” He emphasized that lack of diversity among trial participants will affect our ability to gauge its curative potential in certain groups, or our understanding of unexpected or severe side effects in some other groups.
Opposition from Drug Manufacturers
Regulatory mandates enforced by the National Institutes of Health (NIH) and the FDA over the past two decades have forced drug manufacturers to report on the diversity of their clinical trials. Despite these mandates, diversity numbers, and their reporting, remain low.
During her testimony before the House Energy & Commerce Subcommittee on Health, Lucy Vereshchagina, PhD, representing the trade group Pharmaceutical Research and Manufacturers of America, pushed back on mandates. While acknowledging the need for a concerted effort by all stakeholders—including the drug industry, policy makers, patient and community organizations, medical providers, and regulators—to bring about change, she cautioned that “additional mandates for sponsors would have serious unintended consequences of reinforcing rather than overcoming known barriers to participation for patients, including unfeasibly large and long studies, delayed access to medicines, or disincentives for industry to invest in highly risky therapeutic areas.”
Provisions within multiple bills have been developed to address this diversity issue:
CURES 2.0: Section 203 of this Act:
- Requires an update from the FDA on their efforts to improve diversity in clinical trials
- Requires a study from the Government Accountability Office on barriers to clinical trial participation
- Mandates HHS to conduct a public awareness campaign, especially targeted toward minority communities, to improve awareness and understanding of clinical trials
- Establishes a task force to make clinicaltrials.gov more user- and patient-friendly
DIVERSE Trials Act: Squarely focused on diversity in trials, this bill expands reporting by labs that test for and diagnose COVID-19 and needs a study on data collection and data sharing during a public health emergency. It requires the FDA to issue guidance on decentralized clinical trials, including those executed via telemedicine and other digital health technologies.
DEPICT Act: Provisions within this bill require:
- Pre-market reporting of diversity plans for clinical trials
- Authority for the FDA to mandate post-approval studies or post-market surveillance if demographic subgroup data are insufficient
- An annual report from the HHS, via the FDA, that shares progress on increasing diversity in clinical trials and study enrollment
- NIH-driven activities of community outreach and engagement among underserved communities to improve recruitment of underrepresented minorities in clinical research and trials
- Grants from the Health Resource and Services Administration for community health centers to be able to participate in clinical trials and research
As Dr. Mesa said during his testimony, “Of course, there is no silver bullet for fixing the current lack of diversity in clinical trials. No single piece of legislation can finish the job and allow us to turn to other work. This effort will take sustained attention and a willingness to act intentionally. But the results would be life-changing: improved outcomes for patients.”
Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.