Control of false positives in randomized phase III clinical trials

Changyu Shen1, Ziyue Liu1, Huiping Xu1

  • 1a Department of Biostatistics, School of Medicine, Richard M. Fairbanks School of Public Health , Indiana University , Indianapolis , IN , USA.

Summary

This study estimates the proportion of null or negative efficacy (PNN) in U.S. Phase III clinical trials. The findings suggest a low PNN, indicating a small number of false positive results from these critical medical intervention evaluations.

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