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Abstract:
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Background: The U.S. Food and Drug Administration conducts on-site inspections and data audits through Bioresearch Monitoring program. It is important to inspect the study sites that are different compared with other sites in clinical studies and to identify the problems related to those sites. Usually one cannot inspect all the sites in a clinical study due to limited resources, and statistical tools are needed to help in selecting sites for inspection. Methods and Results: We propose two technical approaches, namely Fisher combination approach and likelihood ratio test (LRT) approach, for site selection, with each approach integrating the information obtained from a p-value matrix. The proposed approaches produce site rankings, and the sites with highest rankings may be selected for inspection. The proposed methods are shown, through extensive simulations, to control false discovery rate, while maintaining good sensitivity. Discussion: The proposed approaches will be useful for site selection process. However, limitations exist when only using the statistical approaches proposed here. Future research topic is discussed to facilitate practical application of the approaches.
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