What You Should Know:
– Trinity Life Sciences, a leader in global life sciences commercialization solutions, has released a new white paper titled “Diversity in Clinical Trials: Life Sciences Initiatives and Challenges in Light of the FDA’s Latest Guidance.”
– The paper sheds light on the critical issue of racial and ethnic diversity in clinical trials, exploring current industry initiatives, their effectiveness, and the future landscape shaped by the FDA’s evolving guidance.
The Importance of Diversity in Clinical Research
The research emphasizes the importance of diverse clinical trial populations in achieving equitable healthcare. When a wider range of racial and ethnic backgrounds are represented in trials, the resulting treatments are more likely to be effective for the entire population they are intended to serve.
Barriers to Diverse Participation
A significant finding is that one-third of executives interviewed by Trinity identified mistrust in the healthcare system as a major obstacle to achieving diversity. This mistrust stems from historical abuses in clinical trials and negative experiences with traditional healthcare. Concerns about the quality of care received during trials and lingering anxieties based on past injustices contribute to a reluctance, particularly among lower socioeconomic communities, to participate in research.
The Role of the FDA
The paper highlights the US Food and Drug Administration’s (FDA’s) role in shaping the future of clinical trial diversity. In 2022, the FDA released draft guidance outlining strategies for pharmaceutical companies to improve participation from underrepresented racial and ethnic groups in clinical trials. As the FDA finalizes these guidelines, pharmaceutical companies are expected to continue prioritizing investments in diversity initiatives.
Industry Initiatives: Three Key Areas
The research identifies three key areas where pharmaceutical companies are focusing their efforts to improve clinical trial diversity:
- Collaboration: This includes working with multicultural communities, establishing Diversity Centers of Excellence, and collaborating with a wider healthcare ecosystem – regulators, patients, and other biopharma companies – to create meaningful progress. Strategic partnerships with non-profit organizations focused on health equity are also gaining traction.
- Strategic Realignment: Companies are reviewing and updating their processes to capture and analyze demographic data on race and ethnicity. A commitment to designing trials that reflect the communities they serve is also crucial. Diversity goals are being established based on the disease’s epidemiology.
- Investment: This encompasses contributions to industry-wide partnerships, developing tools to measure diversity efforts, and building strong relationships with community-based organizations that serve underserved populations.
“Identifying opportunities to promote inclusive participation in clinical trials is a multifaceted, challenging effort, yet it is critical to ensure representation,” explained Lisa Bailey, Managing Director & Head of DEI Strategy at Trinity Life Sciences. “The findings in this new research outline actions life sciences companies are taking to manage the inherent challenges in achieving diversity in clinical trials, and ultimately, to improve health equity.”
