Diversity has always mattered in clinical trials and health care in general. As the National Institutes of Health (NIH) notes, “people may experience the same disease differently.” With a more diverse pool of clinical trial participants, researchers can better account for these differences and support medical advancements that benefit the broader population.
Diversity in crucial to reducing health disparities and ensuring more equitable access to treatments.
For almost 10 years, diversity in clinical trials has been a hot topic among patient advocacy groups and others; now, it’s inching closer to being a mandate. Seeing the ongoing underrepresentation of minority demographics in clinical trials, the Food and Drug Administration (FDA) has taken steps to close health equity gaps.
As guidance on diversity in clinical trials from the FDA and institutional review boards continues to evolve, we're providing an overview of where things stand today.
Why Diversity In Clinical Research Is Essential
People from different socioeconomic backgrounds have historically been excluded from many clinical studies. That means many trials did not account for genetic variations that impact how the same medicine is metabolized among different groups and the likelihood of side effects. Additionally, these individuals may not have equal access to treatment available to their peers in different communities, creating an even wider gap.
A recent analysis of participants for cancer clinical trials found numerous groups continue to be underrepresented in clinical research, including older adults, women, Asians, Hawaiians, Pacific Islanders, American Indians, Alaska Natives, and Hispanics. As the study notes, "people can respond differently to treatments depending on their biology, including ancestry and biological sex."
Clinical research that includes a diverse population of clinical trial participants increases confidence that new treatments will be safe and effective for everyone. This improves outcomes for clinical trials and more importantly, can improve health equity and patient outcomes.
Diversity is especially important with the advent of genomic medications. Gene therapy and some cancer medications only work on cancers with certain genomic variations.
An example is Trastuzumab (Herceptin) for breast cancer, a targeted cancer drug that works by binding to the HER2 receptor, a protein that's encoded by the ERBB2 gene and controls how cells grow, divide, and repair themselves. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. When there are too many HER2 genes and receptors, it can trigger cells to multiply quickly and lead to cancer.
The FDA’s Current Guidance on Diversity in Clinical Trials
In October 2016, the FDA issued a guidance document on the collection of race and ethnicity data in clinical trials. This non-binding recommendation encouraged clinical trial sponsors and sites to start systematically planning for better inclusion of diverse participants. That included submitting a plan to address the inclusion of clinically relevant subpopulations for drugs and biologics. As the FDA notes, “inadequate participation and/or data analyses from clinically relevant subpopulations can lead to insufficient information pertaining to medical product safety and effectiveness for product labeling.”
Fast forward to April 2022, when the FDA expanded upon its original guidance in a 12-page document. The new guidance provided recommendations on what sponsors should include in a Race and Ethnic Diversity Plan to outline their strategies for enrolling and retaining a diverse clinical trial. Examples include:
- An overview of the trial’s disease/condition of focus, with any available data on its prevalence across underrepresented racial and ethnic populations
- The scope of the clinical trial, from study design and study population to endpoints and expected geographic locations
- Enrollment goals for underrepresented racial and ethnic populations, as based on disease epidemiology and/or a priori knowledge that affects outcomes across racial and ethnic groups
- A plan of action to enroll and retain diverse clinical trial participants, including strategies to support site location and access, community engagement, and reducing burdens
- Defined metrics to meet enrollment goals, alongside actions sponsors will take if planned clinical trial enrollment goals aren’t met
- A plan and justification for data collection in a post-marketing environment if enrollment goals can’t be met, despite the sponsor’s best efforts
Alongside these recommendations, the document also made note of two legislative proposals: the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act.
The Shift From Trial Diversity Recommendations to Legislation
These pieces of legislation would mandate diversity plans from clinical trial sponsors. These plans would include enrollment targets broken down by age group, sex, race, and ethnicity and strategies for meeting these targets. In the event that sponsors did not meet diversity enrollment targets, the FDA would have the authority, in some cases, to require further studies or surveillance after medical drug or device approval.
In light of this legislation, failure to adequately represent diverse populations in clinical trials would leave sponsors with financial burdens. While dedicating more time and resources toward research, there’s also protracted time-to-market. Delays in drug or device approval translate into longer periods without revenue, which can cost hundreds of thousands to millions of dollars per day.
Preparing for New Clinical Trial Diversity Standards
With diversity in clinical trials positioned to become law, now is the time for drug and medical device companies to establish more inclusive processes. On the one hand, study protocols should be designed in collaboration with community stakeholders and provide a degree of accessibility that reduces the burden of participation. At the same time, there must be targeted recruitment and retention efforts to sustain participation.
Research shows that 80% of delays in clinical trial timelines are caused by patient recruitment and retention. With the need to enroll a more representative clinical trial participant pool, enrollment and engagement can become even more complex and labor intensive.
At Remington-Davis, we have a proven track record of supporting customers with rapid study subject enrollment. With almost 16,000 volunteers in our database, we can help get clinical trials that meet current diversity standards up and running faster. We’re proud to have a 35% patient diversity rate. And with a 98% patient retention rate, you can be confident in our ability to keep patients engaged.
Learn more about the support we can provide as a clinical site provider. Contact us for additional information.