Endocrine Insider
June 14, 2007

The Endocrine Society has engaged in a continuing project to improve the participation of racial and ethnic minorities in clinical research. The Society’s recommendations, developed by a task force of thought leaders on the topic, were released during a special program during ENDO 07. The task force comprised Society members and non-member representatives from each of the stakeholder groups that have a vested interest in the problem, including researchers, community leaders, the pharmaceutical industry, and government agencies. The project is an initiative of the Government Relations Committee (GRC) and is funded in part by a grant from the Robert Wood Johnson Foundation. Dr. Maria Alexander-Bridges, a member of the GRC, spearheads the effort.

The full white paper has not yet been published, but the recommendations can be viewed at White Paper Recommendations.  The Society will use the paper and its conclusions in advocacy efforts with policymakers and regulators and in outreach to organizations that may help implement the proposed changes.

Some examples of the recommendations include:

• Congress should pass legislation requiring FDA to adhere to inclusion policies similar to legislation requiring NIH-funded trials to adhere to such policies.
• FDA should consider adopting NIH guidelines on the inclusion of women and minority populations.
• FDA should require rather than recommend adherence to its guidelines.
• NIH and academia should establish and maintain an infrastructure of minority patient populations from which individual investigators can easily and efficiently recruit volunteers.

Research and the assembly of the paper represent the first phase of the project. The next phase is to disseminate the information and to advocate for change.

ENDO 07 featured two programs resulting from the project. The above-mentioned special program featured a panel-led discussion of the issues and the Society’s recommendations. Panel members included members of the Society’s task force and other interested parties. Additionally, there was an official ENDO 07 symposium featuring presentations by key members of the task force. Each presentation addressed the issues from a unique perspective.