FDA Drug Trials Snapshots and Diversity When Testing New Drugs

FDA Drug Trials Snapshots and Diversity When Testing New Drugs





FDA Drug Trials Snapshots and Diversity When Testing New Drugs

By: John J. Whyte, M.D., M.P.H.

Over the past two years, FDA’s Center for Drug Evaluation and Research (CDER) approved 67 novel drugs. So it’s no surprise that in recent years, representation in clinical trials of certain subgroups, such as people of different ages, races, ethnic groups, and genders, has become of growing interest. 

To help keep the public better informed, CDER piloted the Drug Trials Snapshots program two years ago to provide easily accessible information about patient representation in clinical trials. Snapshots show who participated in the studies used to approve a novel drug and organize information from the studies by sex, race, and age subgroups.… Continue reading →