CTTI has published recommendations to enhance the functioning of data monitoring committees (DMCs) for clinical trials. Sponsors, DMC members, and all those involved in clinical trial design and conduct can apply CTTI’s recommendations to improve DMC operation and the quality of trial oversight, which ultimately benefits patients.
The monitoring of accumulating data in a clinical trial helps to ensure participant safety, as well as the validity and integrity of the trial. For an increasing number of trials, this is accomplished through an independent DMC that can advise on whether to continue, modify, or terminate a trial based on a benefit-risk assessment. Though DMCs play an important role in the oversight of clinical trials, there is considerable variability in how they are composed and operate.
CTTI’s recommendations, which appear in the journal Clinical Trials, address the following areas:
The recommendations were developed through a consensus of experts from multiple stakeholder groups after collecting and analyzing data on DMC practices.
Learn more about CTTI’s Data Monitoring Committees Project.