FDA releases action plan to encourage greater patient diversification in trials

Posted September 17, 2014

The FDA has released an action plan aimed at encouraging more diverse patient participation in drug and medical device clinical trials.

The plan, released last month, lays out priorities for increasing both trial participation and the reporting of patient demographic data. It follows an August 2013 report to Congress on these concerns.

FDA regulations already require some amount of reporting on patient demographics. Companies submitting investigational new drug applications, for example, must provide the FDA with annual reports tabulating patients’ age, race and gender. Drug- and devicemakers are also encouraged to enroll patients whose age, gender, race and ethnicity reflect the most affected populations; they must also include this information in study protocols.

Nonetheless, industry, patient advocacy groups and healthcare professionals say clinical trials rarely enroll enough women, minorities and elderly patients to be consistent with disease prevalence. Adding to this underrepresentation is a lack of awareness about the potential benefits of participating in clinical trials.

View the action plan on the FDA site. Read the full article (subscription required).