FDA Draft Guidance Explained: “Use of Data Monitoring Committees in Clinical Trials”

The FDA issued draft guidance for industry, titled “Use of Data Monitoring Committees in Clinical Trials,” to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) would be useful for trial monitoring and what procedures and practices to consider to guide their operation. 

This draft guidance, according to the Federal Register, “pertains primarily to the sponsor’s responsibility for clinical trial management and decision making, but may also be relevant to any individual or group to whom the sponsor has delegated applicable trial management responsibilities.”  

David Litwack, PhD, a Board Member of PRIM&R and Associate Vice President for Scientific Strategy and Communications at Prevail Therapeutics, and Albert J. Allen, MD, PhD, a member of PRIM&R’s Public Policy Committee offered their thoughts to help the PRIM&R community understand the ramifications of this draft guidance.   

“DMCs are critical to the protection of clinical trial participants in a variety of settings, including studies involving new technologies or in those that use complex trial designs,” wrote Dr. Litwack. “FDA’s draft guidance on the use of DMCs in clinical trials is an important update that addresses new challenges arising from these more challenging and often higher-risk studies.” 

In his remarks, Dr. Allen explained that this draft guidance “is basically an update of FDA’s 2006 Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees (fda.gov) to address significant changes that have occurred in the structure and practice of Data Monitoring Committees (DMCs), also known as Data Safety Monitoring Committees (DSMBs), Data Safety Monitoring Boards (DSMBs) and Independent Data Monitoring Committees (IDMCs).”   

Dr. Allen elaborated, “Some of the changes include: (1) an increase in the use of DMCs in clinical trials of modest size, (2) a trend for DMC charters to become longer and more detailed, (3) an increased use of DMCs to implement certain adaptive clinical trial designs, (4) an increased use of some DMCs to oversee an entire clinical development program rather than a single clinical trial, (5) the potential for expansion of functions of a DMC; for example, for review of aggregate data for safety reporting for trials under an investigational new drug application (IND), and (6)  an increased globalization of medical product development and use of multiregional trials with DMCs.”  

“The draft guidance reviews the history of DMCs and the evolution of their structure and changes in both the main text and a useful appendix,” Dr. Allen said. “Variations in the structure and practice of DMCs is also reviewed with important recommendations provided regarding how to maintain the scientific integrity in different situations.”   

Dr. Allen concludes, “This draft guidance is directed at industry, but there is much in it that will also be of interests to IRBs, investigators and ethicists.”  

When finalized, the federal notice states, this new guidance “will supersede the final guidance for clinical trial sponsors entitled ‘Establishment and Operation of Clinical Trial Data Monitoring Committees,’ issued in March 2006.” 

Together, the PRIM&R community can offer important perspectives and be a valued voice in shaping federal policy. Share your thoughts with the FDA about this draft guidance. The deadline for submitting a comment is April 15.