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USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials

Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices and Radiological Health and Center for Drug Evaluation and Research released draft guidance on "Use of Data Monitoring Committees in Clinical Trials" for comments.

A clinical trial data monitoring committee (DMC) is a group of individuals with relevant expertise that reviews accumulating data regularly from one or more clinical trials and recommends to the sponsor whether to continue, modify, or stop a trial or trials. A clinical trial DMC is established by the sponsor but should be independent of the sponsor and the trial conduct. A prominent responsibility is also to help ensure subject safety.

This guidance is intended to provide recommendations to help sponsors of clinical trials determine

  1. when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB) a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for clinical trial monitoring and

  2. what procedures and practices they should consider to guide their operations.   

The guidance pertains primarily to the sponsor's responsibility for clinical trial management and decision-making, but may also be relevant to other individuals or groups who have been delegated appropriate trial management responsibilities by the sponsor.

The independence of a DMC depends on the relationships of its members to those sponsoring, organizing, conducting, and regulating the trial. DMCs recommend to sponsors whether to continue, modify, or discontinue trials; sponsors decide whether to accept recommendations to discontinue trials. The sponsor makes the final decision on whether to discontinue a trial.

To understand whether to use a DMC in a development program to use a DMC click this LINK.


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