FDA Revises Guidance on Use of Diverse Data in Clinical Trials

The FDA is proposing to update its guidelines on the collection and reporting of race and ethnicity data used in clinical trials and in the medical products it regulates.

The Food and Drug Administration relies on diverse data collected for clinical trials such as sex, age, race, ethnicity, location, and other characteristics to represent different groups within a population.

Monday’s draft guidance outlines the agency’s current expectations and recommendations for collecting and reporting race and ethnicity data in submissions.

The draft guidance revises a 2016 final guidance.

The new draft guidance provides recommendations on:

• meeting requirements on regarding presentation ...