The Endocrine Society developed recommendations designed to increase minority participation in clinical research undertaken to discover new biomarkers of disease and to develop medications and technologies to treat illnesses.
All stakeholders—including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), Congress and researchers from both pharmaceutical companies and academia—should:
- Hold a summit to reach consensus on definitions of ethnicity and race as well as guidelines on the appropriate participation rates in clinical trials of various racial and ethnic groups. Participation rates may vary, depending on the specifics of a given study, because some diseases are more prevalent in certain population subgroups than others.
The FDA should:
- Adopt, and then require clinical researchers to adhere to, guidelines on minority participation rates in clinical trials.
The NIH should:
- Provide grants to entrepreneurs who want to set up companies dedicated to recruiting diverse populations to participate in clinical studies. These companies could be modeled after contract research organizations, which recruit physician's practices—and their patients—for clinical trials run by pharmaceutical companies.
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