CluePoints Signs Agreement to Help FDA Identify Trial Sites for Inspection

October 18, 2016

The FDA signed a Cooperative Research and Development Agreement with CluePoints to develop software to identify clinical trial sites that should be prioritized for agency inspection. The CRADA’s objective is to use a data-driven approach to select sites that exhibit data anomalies indicative of fraud, misconduct or sloppiness.

The FDA and CluePoints plan to create an ordered list of anomalous sites whose data are highly inconsistent with data from other sites; explore moderators of treatment effect, including factors such as center, region or country, that have a statistically significant impact on the magnitude of treatment effect; and develop a user-friendly interface for use by medical reviewers and other interested parties at the FDA.

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