Interim Analysis: What Regulatory Affairs Professionals Need to Know

A data monitoring committee (DMC) is often responsible for monitoring a clinical trial via interim analyses. Those responsible for regulatory strategy and implementation need to be fully engaged with this oversight process to ensure that the trial will achieve its goals with regulators. In the United States, both 21 CFR 312.50 and 21 CFR 312.56 describe sponsor responsibilities related to ongoing clinical trials conducted under an Investigational New Drug Application. Herein, I review the types of trials that may benefit from DMC involvement and provide an example of a DMC clinical trial model. I highlight important features of the roles of the sponsor, DMC, statistician, and the regulatory professional in interim analysis. I review the importance of early planning, knowing when to release interim data, and avoiding type I error rate inflation. Finally, I examine key points that lead to early stopping or study alteration.