ICH E10 Choice of Control Group in Clinical Trials Guidelines

E10 Choice of Control Group in Clinical Trials

E10 Choice of Control Group and Related Issues in Clinical Trials

The ICH harmonised Guideline was finalised under Step 4 in July 2000. This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence / non-inferiority trials that limits the usefulness of trial design in many circumstances.

Date of Step 4: 20 July 2000

Status: Step 5

Guidelines (Click the links below for complete guidelines)

E10 Guidelines

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