Robert H. Dworkin

Interpreting the totality of clinical study data: is there a better way? Statistical methodology for quantitatively interpreting clinical study data across efficacy endpoints.

INTRODUCTION Interpretation of the efficacy of an intervention in clinical trials often relies on whether the p-value for the primary endpoint is <0.05, with less emphasis on the pattern of results across efficacy endpoints. When results across endpoints are consistent and strongly supportive (or unsupportive) interpre...