March 10, 2025: Developing Monitoring Plans Warrants Special Attention in Pragmatic Clinical Trials
Rethinking Clinical Trials
MARCH 10, 2025
In an article published online ahead of print , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk. Challenges specific to pragmatic trials include: complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites embedding of interventions in clinical
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