FDA addresses expanded use of data monitoring committees in draft guidance
The FDA laid out considerations for how sponsors should leverage committees to help analyze clinical trial data in draft guidance published Monday. The draft arrives as the use of these data monitoring committees has increased over the past several years.
The 29-page document, once finalized, will replace the FDA’s 2006 guidance on the topic, titled Establishment and Operation of Clinical Trial Data Monitoring Committees. The updated guidance addresses an increased use of data monitoring committees over the past several years, as well as the expanded scope of what data monitoring committees are used for.
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