Issue Date: September 16, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E9 Statistical Principles for Clinical Trials
The efficacy and safety of medicinal products should be demonstrated by clinical trials that follow the guidance in E6 Good Clinical Practice: Consolidated Guidance adopted by the ICH, May 1, 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guidance. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. This guidance is written primarily to attempt to harmonize the principles of statistical methodology applied to clinical trials for marketing applications submitted in Europe, Japan and the United States.
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