ICH E10 - Choice of Control Group in Clinical Trials

What it says

E10 discusses the choice of control group in clinical trials and the associated issues of design and interpretation. It describes the five types of control, placebo, no-treatment, dose-response, active and external, the strengths and limits of each, the ethical considerations, and the need for assay sensitivity to detect a difference where one exists, particularly in non-inferiority trials.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The choice of control determines what question the trial can answer, so it should match the objective.
• Placebo control may raise ethical concerns where effective treatment exists and delay carries risk.
• Non-inferiority designs depend on the assumption that the active control would beat placebo in the trial.

What inspectors look for

• Whether the choice of control is justified in the protocol.
• Whether blinding and randomization protect against bias.
• Whether the margin used in a non-inferiority trial is justified.

Related regulations