The 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.
The FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during clinical research. Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk. With the volume of product submissions, the FDA can only inspect a small proportion of clinical trial sites. The determination of which sites to inspect can involve recommendations by clinical and statistical reviewers, CDER’s Risk-Based site selection tool and FDA inspectors’ judgment and experiences.
The initial Cooperative Research and Development Agreement (CRADA) between FDA and CluePoints began looking at a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. Under this CRADA, FDA and CluePoints, Inc. have developed and tested enhancements to CluePoints’ existing software to produce an ordered list of “anomalous sites”; added statistical tests and models to those already in the software; refined the scoring system used to identify outlying centers.