Using Data & Safety Monitoring Boards: From Planning to Execution

By Maxim Kosov

Senior Medical Advisor, Operations

Is a DSMB right for your study?

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, and one such body is a Data and Safety Monitoring Board (DSMB) – also known as a Data Monitoring Committee (DMC). 

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. However, the role of DSMBs has evolved since their initial creation, making their management more challenging and complicated. 

Read our new white paper to learn about: 

  • How the role of the DSMB has evolved in recent years and current challenges in DSMB management 
  • When a DSMB is needed  
  • The primary considerations for committees to maintain eligibility, credibility, and high-quality outcomes 

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

Antibiotic development is notoriously underfunded, but PSI meets enrollment rates 23% higher than the industry average. See how PSI supported this sponsor by leveraging site relationships for the most pragmatic site selection.

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Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

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