By: Jennifer Dexter, AVP, Policy

On June 13, The National Health Council (NHC) submitted comments on the FDA Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. The NHC appreciates that the FDA issued this guidance and is continuing efforts to increase diverse participation in trials. The guidance requires that trial sponsors create a diversity plan that would be submitted to FDA. This guidance is in line with FDA user fee legislation that the House of Representatives has passed that would have similar requirements. The Senate companion legislation does not include any clinical trial diversity language.

Increasing the participation of people from marginalized populations in clinical trials is a primary focus of the medical innovation policy recommendations reflected in the recommendations of our report, Access, Affordability and Quality: A Patient-Focused Blueprint for Real Health Equity.

Some of our specific recommendations focused on key areas including:

• Patient and Community Engagement Aspects of the Diversity Plan
  • Encouraging the FDA to add a category to the plan components on patient and community engagement.
• Timing of Plan Submissions
  • Urging the FDA to prioritize submission of diversity plans “as soon as practicable” to allow for identification of safety signals and disparities earlier in development.
• Tracking Research Team Demographics
  • Recommending that the plans also include information on the demographic makeup of the research team.
• Continued Focus on All Marginalized Populations
  • Encouraging the FDA to issue future guidelines that help sponsors engage all marginalized populations.
• Using Diversity Plans to Develop Best Practices
  • Recommending that the FDA monitor and collect best practices as this guidance is implemented.

Read the full letter here.