Diversity in clinical trials is essential for generating data that reflects real-world populations. Historically, however, this diversity has been limited due to systemic challenges, cultural barriers, and a lack of trust among underrepresented communities. As someone deeply involved in clinical research, I believe that addressing these barriers is not just an ethical imperative — it is a scientific necessity.
Recent guidance from the FDA underscores this urgency by requiring diversity action plans for Phase III trials. These plans aim to ensure that clinical data adequately represents the demographic makeup of the populations most affected by specific diseases. This approach is critical for understanding differences in how treatments work across various groups and for ensuring equitable access to medical advancements.
The Impact of Underrepresentation
Historical underrepresentation of minority groups in clinical research has led to significant gaps in our understanding of how treatments affect diverse populations. For instance, differences in genetics, environment, and lifestyle can all influence how a drug works, yet these factors are often underexplored in trials dominated by homogenous participant pools. This lack of representation has real consequences, as it can result in side effects or efficacy issues that only become apparent after treatments are released to the broader public.
Underrepresentation perpetuates health disparities; and when clinical trials fail to include all groups, they deny some populations the potential benefits of cutting-edge treatments. The exclusion of diverse voices also risks widening the trust gap between medical researchers and underrepresented communities.
An example of racial/minority underrepresentation in clinical trials is the case of BiDil (a combination drug of hydralazine and isosorbide), a drug approved in 2005 for heart failure treatment in African Americans. Initial trials, which included primarily white participants, did not show significant benefits based on the study results. However, when tested in African Americans, the drug was found to be effective in reducing mortality rates for this group. The U.S. Food and Drug Administration (FDA) approved BiDil as the first drug specifically marketed for African Americans with heart failure, highlighting the importance of conducting clinical trials that adequately represent diverse racial groups. This case underscores the need for inclusive studies to ensure treatments are effective across different populations.
Barriers to Participation
Numerous barriers hinder the inclusion of diverse participants in clinical trials. On an individual level, mistrust of the medical system—fueled by historical injustices like the Tuskegee Syphilis study—remains a significant obstacle. Many individuals are also unaware of clinical research opportunities or face logistical challenges such as transportation, time constraints, and financial difficulties.
At the interpersonal level, healthcare providers often do not discuss clinical trial opportunities with their patients. This could be due to a lack of awareness by the healthcare providers, institutional constraints, or skepticism about research. Institutional barriers, such as a lack of infrastructure in underserved areas, further limit access. Finally, policy-related gaps in the healthcare and research systems also exacerbate these challenges. These include, but not limited to, lack of robust safeguards for participant rights, and insufficient policies to ensure inclusive protocol/trial designs.
Breaking Down Barriers
At Elligo Health Research, we’ve developed several initiatives to overcome these obstacles and foster trust among underrepresented communities. Key strategies include:
- Embedding Research in Local Communities: By partnering with trusted physicians in diverse areas, we bring clinical trials closer to the populations we aim to serve.
- Building Culturally Competent Teams: Employing staff from diverse backgrounds helps bridge cultural and linguistic gaps, making participants feel more understood and respected.
- Offering Reasonable Compensation: Providing adequate compensation for participants’ time and effort demonstrates respect for their contributions and removes some financial barriers.
- Promoting Awareness: Engaging with community leaders and organizations helps spread awareness of clinical trials and their benefits.
- Conducting Hybrid and Decentralized Trials: By conducting hybrid and decentralized trials, we give individuals the opportunity to be involved in clinical research by removing/limiting barriers such as travel concerns and time constraints.
By implementing these strategies, we aim to create a more inclusive research environment that benefits all populations. Clinical trials should be a bridge to equitable healthcare, not a barrier.