Gender diversity in clinical trials

Dr Nicola Davies reports on what the US Food and Drug Administration (FDA) is doing to promote female participation in clinical trials.

The importance of diversity in clinical research cannot be underestimated - the findings of these studies are used to determine whether a new drug, device, or treatment process is safe, efficacious and efficient for all prospective recipients. However, evidence suggests there are physiological and/or genetic distinctions between genders that can influence disease-risk, severity, and response to a treatment. And yet despite this evidence, notable disparities exist in clinical trial participation, with women continuing to be under-represented.

The FDA and National Institutes of Health (NIH) have attempted to bring necessary reforms into both regulatory and practical frameworks, but female participation rates continue to remain low. For instance, only 46% of all clinical trials conducted in 2015 included women. This raises several critical questions around what the FDA is doing to increase gender diversity in clinical trials.