Perspectives on Enquiry & Evidence

The FDA’s New Draft Guidance on DMCs: What to Know

Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinical trials. New draft guidance published by the U.S. FDA on the use of DMCs in clinical trials provides six major updates to the FDA’s expectations regarding DMC structure and practice.

We highlight the updates provided in this draft guidance and discuss the impact on sponsors.