Over at the FDA blog, Commissioner Califf (who Seth blogged about here), declares 2016 to be the year of diversity in clinical trials. Dr. Califf notes that “…it’s generally agreed that the composition of the population enrolled in a trial should help FDA reviewers, clinicians, or policy makers to have confidence that the trial results will apply to future practice.”

However, “historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. A substantial body of literature has documented this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials.”

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