The Value Of Continuity: Program-Level DSMBs

By Barbara Schneider, PhD, MBA, Executive Director, Biostatistical Services; James Riddle, MCSE, CIP, CPIA, CRQM, SVP, Global Review Services

The use of Data Safety Monitoring Boards (DSMBs) in pharmaceutical development is crucial for ensuring the safety and efficacy of new treatments. Traditionally, a new DSMB is formed for each trial, but there is a growing recognition of the benefits of utilizing the same DSMB members to oversee multiple trials within a therapeutic program.

By using the same DSMB members across all trials in a series, there is continuity of experience, allowing the members to develop a deep understanding of the drug and its potential safety concerns. This enables the DSMB to provide more informed recommendations throughout the entire program and detect subtle changes in safety data over time. Utilizing the same DSMB members also leads to faster setup times, as the members are already contracted and trained on the technology systems. This reduces administrative burdens and allows the DSMB to be ready to cover the next trial within a couple of weeks. There are also cost savings associated with using the same DSMB members, as forming a new DSMB for each trial requires time and resources.

By streamlining the process and reducing administrative burdens, there are potential cost savings. The importance of continuity in data monitoring is emphasized by recent FDA draft guidance on DSMBs, which highlights the benefits of having a single DSMB oversee an entire therapeutic program.

Discover the strategic benefits of deploying consistent DSMB members across therapeutic programs, highlighting the pivotal role of program-level supervision in safeguarding the safety and effectiveness of novel treatments.