As Prescribed


Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). Since the original guidance was published in 2006, the agency has noticed an uptick in not only DMC usage but also broader DMC functions. As DMC use has changed, the guidance provides detailed considerations for sponsors regarding a variety of areas, including when a DMC may be appropriate, the scope of DMC responsibilities, and how to properly set up a DMC.

Our in-depth look at the guidance, as well as insight into how and when DMCs should be implemented, can be found here, but some of the key takeaways are as follows:

  • Clinical trial sponsors should carefully consider the need for a DMC for their particular trial. In some trials, a DMC can provide an additional layer of subject protection and a way to ensure that the trial is continually fit for its intended purpose, but in others a DMC may not be able to be usefully operationalized or the DMC functions may be better served by a different monitoring group.
  • If it is determined that a DMC is appropriate for a study, it is recommended that a DMC become familiar with the study protocol and other pertinent study information, including the DMC charter, prior to participant enrollment.
  • When establishing a DMC, its responsibilities must be clearly set out in the charter. This will reduce conflicts among DMC members and eliminate possible confusion later on regarding the role of the DMC in the particular study.
  • DMC independence from the sponsoring organization is critical to reducing possible bias and improving the DMC’s objectivity.

Interested stakeholders should comment on this draft guidance, with the comment period currently open until April 15, 2024.