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GUIDELINE Draft Step 2 Draft

E20 Adaptive Designs for Clinical Trials

E20 International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

ICH guideline on adaptive clinical trial designs. Pre-specified modifications based on interim analyses. Step 2 endorsed June 2025, public consultation closed.

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METADATA
TypeGUIDELINE
Year2025
VersionStep 2 Draft
StatusDraft
FormatPDF
Pages—
Size—
Last reviewedJUN 2025
SOURCE
PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e20-guideline-adaptive-designs-clinical-trials-step-2b_en.pdf ↗
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