Using Data & Safety Monitoring Boards:
From Planning to Execution
Prepared by Maxim Kosov, MD, PHD
PSI Senior Medical Advisor
With over 20 years of experience managing Data and Safety Monitoring Boards, PSI understands the questions sponsors commonly face when determining whether and how to implement a DSMB.
The Evolution of DSMBs in Clinical Research
When is a DSMB Needed?
Considerations for Establishing a DSMB
Final Thoughts
Schedule a Capabilities Presentation Today
The randomized clinical trial (RCT) is the gold standard for evaluating the benefits and harms of new medical interventions. Safety surveillance is one of the core objectives of every RCT, involving various review bodies and structures. A Data and Safety Monitoring Board (DSMB) – also known as a Data Monitoring Committee (DMC) – is one such body.
A DSMB is an independent group of individuals with relevant expertise external to the study sponsor, charged with a periodic review of clinical trial conduct, efficacy, and participant safety and recommending trial continuation, changes, or termination when appropriate. Since the University Group Diabetes Project introduced one of the earliest DSMBs in the late 1960s, their role has evolved, and their management has become more challenging and complicated.1
A critical difference between DSMBs and other research oversight bodies is that a DSMB periodically reviews study data (both blinded and unblinded) in its entirety, performing risk-benefit assessments throughout the ongoing clinical trial to look for the emergence of serious or unexpected adverse outcomes or signs of a significant beneficial effect.
With over 20 years of experience managing Data and Safety Monitoring Boards, PSI understands the questions sponsors commonly face when determining whether and how to implement a DSMB. This white paper will discuss:
How the role of the DSMB has evolved in recent years and current challenges in DSMB management.
When DSMBs are needed.
The primary considerations for committees to maintain eligibility, credibility, and high-quality outcomes.
Next up: The Evolution of DSMBs in Clinical Research
