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Clinical Trials Need Better Diversity: HHS Cites Work by CHIBE Affiliate

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The Big Takeaway:

Dr. Scott Halpern (a member of CHIBE’s Internal Advisory Board) and colleagues wrote a paper on why diverse clinical trial participation matters, and they articulated several goals, which were cited by the Department of Health & Human Services (HHS) in a recent brief detailing its plans to increase diversity in clinical research.

The Problem:

A lack of diversity in clinical trials can lead to medical mistrust among marginalized communities, issues of fairness, and potentially stagnated biomedical knowledge, the authors of this New England Journal of Medicine paper wrote. Better trial representativeness could “improve the generalizability of research findings, produce new biologic insights, and yield targeted therapeutic strategies,” they stated.

The Proposal:

The authors argued that efforts to improve diversity cannot be sustained if the objectives aren’t clearly articulated. The paper pinpointed 3 main goals:

  1. Earning and building trust
  2. Promoting fairness
  3. Generating biomedical knowledge

The authors also offered several ways to reduce barriers for potential participants including:

  • Providing transportation or parking vouchers
  • Offering compensation or financial incentives
  • Using mobile recruitment strategies
  • Building inclusive trial infrastructure in underserved areas
  • Streamlining the consent process
  • Reducing the use of exclusion criteria

The Impact:

The Office of Science and Data Policy at the HHS published this brief on actions that HHS is taking to enhance diversity in clinical research. The brief specifically names the 3 goals the authors highlighted as key efforts to improve diversity and representativeness in clinical trials.

Additionally, Dr. Halpern was one of approximately 70 guests invited to the White House on June 26, 2024, for its Clinical Trials Forum to discuss efforts to improve the diversity of participants in clinical trials.

“It is wonderful to see our work being recognized by the White House’s Office of Science and Technology Policy and the Department of Health and Human Services,” Dr. Halpern said. “I believe we’re having an impact on national efforts to tackle the important problem of poor representativeness in clinical trial participation, but there is much work to be done above and beyond policy statements and executive meetings.”

Learn More:

Read the New England Journal of Medicine paper “Why Diverse Clinical Trial Participation Matters” written by Aaron L. Schwartz, MD, PhD; Marcella Alsan, MD, PhD; Alanna A. Morris, MD, and Scott D. Halpern, MD, PhD.