Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
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The FDA’s New Draft Guidance on DMCs: What to Know
Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinical trials. New draft guidance published by the U.S. FDA on the use of DMCs in clinical trials provides six major updates to the FDA’s expectations regarding DMC structure and practice.
We highlight the updates provided in this draft guidance and discuss the impact on sponsors.
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March 20, 2017
In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically...
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