Reflection paper on methodological aspects in confirmatory platform trials

EMA (EU)

GUIDANCE FINAL

Published: 10/19/2026Detected: 10/19/2026

Summary preview

Sets out EMA CHMP methodological expectations for confirmatory platform trials, focusing on how to control multiplicity (Type I error), define estimands, and pre-specify randomisation and control strategies.

Get the full analysis, free

Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.

Create free account

clinical

#platform trials

#confirmatory trials

#multiplicity

#Type I error control

#FWER

Official Source Document
Source Verified

Access the original document directly from EMA.

View Official Document

More from EMA (EU)

Get EMA (EU) alerts in your inbox as they are published.

Free plan, 2-minute setup, no credit card required.

Security

Privacy Policy

Terms of Service

Not affiliated with the FDA, EMA, or Health Canada.

Summary preview

Get the full analysis, free

Official Source Document Source Verified

More from EMA (EU)

Get EMA (EU) alerts in your inbox as they are published.

Official Source Document
Source Verified