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Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials

Ubong Peters1,2, Brenna Turner3,4, Daniel Alvarez4,5

  • 1Product Development - Global Clinical Operations, South San Francisco, CA, USA. peters.ubong@gene.com.

Therapeutic Innovation & Regulatory Science
|October 14, 2022
PubMed

Insights

Clinical trials lack diversity, underrepresenting marginalized groups and hindering equitable treatment development. Addressing participation barriers is crucial for public health and reducing health disparities.

Area of Science:

  • Clinical Research
  • Public Health
  • Health Disparities

Background:

  • Clinical trials often fail to recruit diverse populations, particularly historically marginalized individuals.
  • This underrepresentation is disproportionate to disease incidence and prevalence, impacting real-world data.
  • Lack of diversity obscures drug safety and efficacy, exacerbating health disparities.

Purpose of the Study:

  • To analyze the impact of diversity bias in clinical research on public health.
  • To identify barriers preventing marginalized populations from participating in clinical trials.
  • To discuss practical solutions for increasing diversity in clinical trial participation.

Main Methods:

  • This review article provides an in-depth analysis.
  • It examines the impact of bias on public health.
  • It describes barriers and proposes solutions.

Main Results:

  • The lack of diversity in clinical research participation obscures drug safety and efficacy.
  • It limits the development of effective treatments for all patients.
  • This contributes to wider health disparities.

Conclusions:

  • Increasing diversity in clinical trials is essential for equitable healthcare.
  • Addressing participation barriers requires a collaborative effort from sponsors, organizations, patients, and caregivers.
  • Achieving diversity is a necessary goal for improving public health outcomes.
Keywords:
Clinical trialsDiversityHealth equityInclusive researchUnderserved minorities

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