Abstract
Clinical trials provide a way to systematically evaluate clinical outcomes to determine the best available treatment. Independent review of clinical data is critical to ensuring the ongoing benefit of trial participation. Safety monitoring is conducted by a group of independent experts who review efficacy data, review adverse event accumulation, and ensure participant safety. Randomized trials remain a particularly important way to measure a new intervention to currently used treatments. The independent review of these studies with an evaluation of trial efficacy and futility is critical to ensure ongoing trial integrity. Awareness of trial monitoring and objectives can reduce the administrative burden for the principal investigator and regulatory staff. This chapter will provide an introduction to clinical trial monitoring committees and their role in safety monitoring.
Published Version
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