Trinity Life Sciences Investigates Diversity in Clinical Trials as Stakeholders Prepare for FDA Guidance to Become Final

Trinity Life Sciences, a leader in global life sciences commercialization solutions, release research on clinical trial diversity with a focus on racial and ethnic minorities in a new white paper, titled Diversity in Clinical Trials: Life Sciences Initiatives and Challenges in Light of the FDA’s Latest Guidance. The paper outlines initiatives that are being undertaken at the corporate level to improve the diversity of clinical trials, the effectiveness of those initiatives and the impact of the U.S. Food and Drug Administration (FDA)’s guidance to improve diversity now and in the future.

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Lisa Bailey, Managing Director and Head of DEI Strategy at Trinity Life Sciences, participates in an energetic strategy session in May 2024. Photo credit: Trinity Life Sciences

One-third of executives interviewed in Trinity’s research explicitly mention that mistrust in the healthcare system remains a significant barrier to diverse enrollment in clinical trials due to several factors, including historical abuses in clinical trials and negative experiences patients may have experienced with their own medical care. There is reluctance within communities, particularly among those of lower socioeconomic status, to participate in trials due to concerns about the care they will receive and fears based on past abuse.

Diverse clinical trial populations are an integral step in achieving equitable healthcare treatment. In 2022, the FDA released draft guidance for the pharmaceutical industry outlining tactics and plans to improve clinical trial participation from underrepresented racial and ethnic populations within the United States. As the landscape prepares for the FDA guidance to become final, company investment in trial diversity initiatives will continue to be an area of focus.

“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.”

Several activities and initiatives are consistently seen within three broad categories across key pharma companies:

Collaboration

• Working with multicultural communities and establishing Clinical Trial Diversity Centers of Excellence to overcome barriers to appropriate representation in clinical trials.
• Collaborating with regulators, patients, other biopharma companies and the wider healthcare ecosystem to make meaningful progress on diverse participation in clinical trials.
• Making strategic collaborations with non-profits advancing health equity in core therapeutic areas.
  
  

Strategic realignment

• Reviewing and updating processes and systems to capture and analyze demographic parameters such as patient race and ethnicity.
• Committing to designing clinical trials that reflect the racial and ethnic diversity of the communities they serve.
• Establishing diversity goals informed by the epidemiology of the disease.
  
  

Investment

• Contributing to industry partnerships to advance clinical trial diversity initiatives.
• Developing and testing diversity measurement tools.
• Building inclusive community-based partnerships that serve underserved communities.

Life sciences executives are welcome to download the white paper here.

Webinar: Diversity in Clinical Trials

A webinar on July 17, Diversity in Clinical Trials: Evaluating Current Initiatives and the Impending Impact of the FDA’s Guidance, will discuss recent research and developments in clinical trial diversity. Trinity’s Diversity, Equity & Inclusion (DEI) strategy team invites life sciences executives to join a lively discussion with a focus on key topics including:

• What initiatives are being undertaken at the corporate level to improve trial diversity?
• How effective are these initiatives?
• What impact will the FDA’s guidance have on diversity now and in the future?

For more information or to register, click here.

About Trinity Life Sciences

Trinity Life Sciences is a trusted strategic commercialization partner, providing evidence-based solutions for the life sciences. With nearly 30 years of experience, Trinity is committed to revolutionizing the commercial model by providing exceptional levels of service, powerful tools and data-driven insights. Trinity’s range of products and solutions includes industry-leading benchmarking solutions, powered by TGaS Advisors. To learn more about how Trinity is elevating life sciences and driving evidence to action, visit trinitylifesciences.com.

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