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Aims to further explore a data-driven approach to quality oversight in clinical trials
September 11, 2019
By: Kristin Brooks
Managing Editor, Contract Pharma
The FDA has extended its Cooperative Research and Development Agreement (CRADA) with CluePoints to October 2021 to include additional research focused on “moderators of treatment effect” and real-world evidence. Additional analyses based on these moderators of treatment effect will include geographic region, country and supervising Contract Research Organizations (CROs). The FDA also plans to conduct statistical tests provided by CluePoints such as Key Risk Indicators (KRIs) that will supple...
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