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The Federal Drug Administration (FDA) has extended the Cooperative Research and Development Agreement (CRADA) with CluePoints.
The CRADA has been extended 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).
FDA also plans to conduct statistical tests provided by CluePoints such as Key Risk Indicators (KRIs) that will supplement the existing data-driven approach to selecting sites for inspection using a risk-based approach.
Benefits to the FDA of the CRADA’s data driven approach include the detection of anomalous sites which may have escaped detection previously, rapid turnaround of results, the ability to determine the nature and extent of data anomalies, and the ability to explore the interaction of various factors with data quality. These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations.