Lexology February 27, 2024
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial management with recommendations for determining when to engage a data monitoring committee (DMC) for trial monitoring. It also provides recommended procedures and other considerations for DMCs. Once the Draft Guidance is finalized, it will supersede FDA’s March 2006 guidance entitled Establishment and Operation of Clinical Trial Data Monitoring Committees.
In Depth
BACKGROUND ON DMCs
A DMC (often referred to as a data safety monitoring committee) is a group of individuals with relevant clinical, scientific, statistical or other expertise. This group regularly reviews human-subject data accumulating from...
Today's Sponsors
Today's Sponsor