FDA calls on sponsors to create diversity plans before starting trials

FDA’s latest draft guidance seeks to make companies proactive partners in improving minority representation in clinical trials by asking them to create a diversity plan and submit it to the agency ahead of starting trials, including as part of INDs. 

The guidance, announced Wednesday, noted that the underrepresentation of Black, Latino, Native American and other minority groups in clinical trials is worsened by the higher disease burdens of these groups compared with the general population. ...