45: Recent Regulatory Guidance Trends for Randomization Monitoring in Clinical Trials

Music City Center 

Monitoring is a process to ensure that data integrity is maintained across the duration of a clinical trial. Regulatory authorities recommend that Sponsors focus monitoring strategies on data critical to reliability of trial results. As Randomization is considered critical data, recent regulatory guidance (ICH, MHRA, FDA, EMA) places higher focus on Randomization Monitoring. This type of monitoring concentrates on reviewing accumulated randomization data to confirm that randomization has occurred per protocol/relevant specifications. Randomization monitoring is important in every clinical trial to provide verifiable evidence proving the randomization's integrity. It becomes even more crucial in complex innovative designs (e.g., Master Protocols, trials with AI-enabled devices/machine learning) due to their complexity/novelty. This presentation will establish the importance of randomization monitoring (both in standard and complex/novel protocol designs) and summarize regulatory requirements for randomization monitoring (e.g., sponsors' responsibilities, contents of monitoring plans/reports). It will also present guidance for developing an effective randomization monitoring process.

Randomization Monitoring

Clinical Trial Monitoring

Randomization

Regulatory Guidance Review 

Biopharmaceutical Section