E10 Choice of Control Group and Related Issues in Clinical Trials

Issue Date: May 14, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final

E10 Choice of Control Group and Related Issues in Clinical Trials

This guidance is intended to assist applicants in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment. The guidance also discusses related trial design and conduct issues and describes what trials using each design can demonstrate. This guidance does not address the regulatory requirements of any region.

Download the Guidance Document

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