9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product. 

In that spirit, today the U.S FDA issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics (e.g., patients with organ dysfunction, co-morbid conditions, and disabilities; those at weight range extremes; and populations with diseases or conditions with low prevalence).

Read FDA press release