New FDA Guidance On Enhancing The Diversity Of Clinical Trial Populations, And Some Great Related Resources

The FDA recently published a new guidance on diversity in clinical trial populations, which “recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.” The document may be found and downloaded from the FDA website.

In addition to providing guidance on eligibility criteria, enrollment practices, and trial designs, the guidance notes, “Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved. As we all know, however, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials.”