One-Third of Interviewed Executives Explicitly Mention Mistrust in the Healthcare System as a Significant Barrier to Diverse Enrollment in Clinical Trials
June 25 2024 - 8:37AM
Business Wire
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240625903182/en/
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draft guidance for the pharmaceutical industry outlining tactics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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Elizabeth Marshall Trinity Life Sciences
emarshall@trinitylifesciences.com