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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.