Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

Public Comments

Comments provided on: April 15, 2024

Comments provided to: U.S. Food and Drug Administration

The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219). In broad strokes, our comments recommended expanded guidance on the role Data Monitoring Committees can play in actively fostering the safety of trial participants – whether by communicating directly with trial sponsors, IRBs, or with offices within FDA. We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA. As with all our interactions with the FDA, we commend their commitment to setting the global pace when it comes to ensuring the conduct of scientifically sound, risk appropriate, ethical clinical research.