Diseases can impact different population groups unequally. The recent coronavirus proved to be no exception. In the U.S., COVID-19 had a devastating impact in particular on BIPOC (Black, Indigenous, and people of color) communities. The race to develop vaccines for COVID-19 renewed conversations about clinical research and the importance of diversity in trial participation.
Recent studies highlight the lack of diversity and inclusion in vaccine clinical trials. Some populations who are excluded, due to various factors, are also the populations who will most benefit from the study drug once is it approved by the FDA for use.
The FDA actively works to address the lack of diversity and inclusion in clinical trials. In 2020, the FDA issued guidance on increasing the participation of medically complex patients and those who need reasonable accommodations, including non-English speakers. The purpose of inclusion and exclusion criteria in clinical research was examined with emphasis on revisiting the original ethical considerations that contributed to exclusion of a wider segment of the population from clinical trials.
Groups from academia, drug research, health care, and patient advocacy also examine general diversity and inclusion issues in clinical trials.
One such group found that barriers to participation in clinical trials can include:
The findings on minority population participation are confirmed by those involved in the day-to-day conduct of clinical trials. Harish Dave, MD, Chief Medical Officer at AUM Biosciences, observes:
Idania Machado, CCRP, CCRA, Site and Resource Manager at IQVIA also shares her observations:
FDA guidance recommends diversifying trial populations by incorporating a number of practices into future trial design, including:
Strategies to Improve Accessibility. A 2021 workgroup of leaders in the clinical research industry explored how to improve the participation of diverse and underserved/underrepresented populations. Their research revealed the following statistics related to trial demographics:
The work group also addressed these identified barriers to clinical trial participation with the following strategies:
Patient Centric Protocol Optimization
Investment and Advocacy
The recommended actions set forth are still in the early stages of implementation. However, the research community is mobilizing in the direction of expanding trial design to better reflect population demographics. The actions and recommendations, when successfully incorporated into trial design and conduct, will capture data from a more diverse and inclusive patient population. In turn, this data will better reflect the needs of the population for whom the study drugs will one day become beneficial prescribed medications.
 The FDA Reauthorization Act of 2017; “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices and Trial Designs Guidance for Industry”
 Duke University Center for Health Policy workshop “Evaluating Inclusion and Exclusion Criteria in Clinical Trials”
 Advarra Research and Consulting Services