EMA Amends Clinical Trial Disclosure Rules To Support Meaningful Transparency

11 Oct 2023

Revised transparency rules for the EU Clinical Trials Information System aim to deliver earlier publication of key documents of interest to patients and researchers, including study protocols, as well as a significant simplification of the system for sponsors.

Businesswoman pressing face emoticon on the keyboard laptop / Customer service evaluation concept. — Updated CTIS Transparency Rules Will Result In A Less Complex, More Efficient And User-Friendly System • Source: Shutterstock

The European Medicines Agency has adopted revised transparency rules to rationalize the amount of study data that sponsors have to make public via the Clinical Trials Information System (CTIS), the EU portal for making trial-related submissions under the provisions of the Clinical Trials Regulation (CTR).

The emphasis is on publishing fewer documents, but ones that are more meaningful to stakeholders, earlier.