E10: Choice of Control Group and Related Issues in Clinical Trials

Regulatory Resource: E10: Choice of Control Group and Related Issues in Clinical Trials

Description:

The harmonised tripartite guideline was finalised, having reached 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.

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