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Representation of Diverse Populations

Focus Area: Ethical Frameworks

Representation of Diverse Populations

The vast majority of regulatory approvals for investigational products is based on well-characterized, often double-blind, randomized clinical trials. Ideally, the participant population enrolled in clinical trials is reflective of the general population or of the disease distribution, to provide generalizable knowledge pertinent to that population. In most clinical trials, however, sex and ethnicity are underrepresented and not representative of the population at large.  This is particularly problematic for trials of drugs and biologics, as efficacy and safety of medicines can vary depending on several intrinsic and extrinsic factors, including the individual’s genetic background, ethnicity, lifestyle, age, and others.

The MRCT Center is commencing a work group of diverse stakeholders, including academic- and industry-based leaders, not-for-profit institutional representatives, and patients/patient advocates to develop a framework and guidance document to inform multi-regional clinical trial design, recruitment, methodology and analysis focused on the inclusion of diverse subpopulations specifically focused on sex/gender and ethnic differences.

Current Status: Workgroup Initiation

Impact: Development of a systematic guidance document to enhance diversity in multi-regional clinical trials.

Objectives:

  • Identify regulations, policies, and guidance that address considerations of or requirements for inclusion of subpopulations in clinical trials
  • Identify and inventory current methods of recruitment that target underrepresented populations
  • Define terminology, data sources, and inventory methodologies
  • Create resources of current and proposed practices to enhance recruitment of diverse populations
  • Develop a standardized approach for analysis of trial data for diverse subpopulations

Key Milestones:

  • December 2017: Initial meeting of leadership team
  • February 2018: Inaugural meeting of working group 

Project Coordinator: Hayat Ahmed