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EMA- New Guidance on Complex Clinical Trials

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) provided guidance on complex clinical trials (CCT).

This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation.

The scope of this document is to provide guidance and support for complex clinical trials which are defined as being non-conventional in the sense that they have elements, features, methods or combination thereof, including novel approaches, that confer complexity of their designs, conduct, analyses or reporting.

This document aims to address challenges sponsors may face as regards scientific and operational aspects of CCTs and to encourage considering choices in development and implementation as early as possible, in order to generate useful evidence and inform clinical and regulatory decision-making.

This document also refers to additional resources providing guidance for CCTs throughout the medicinal product lifecycle.

This Q&A document is not restricted to specific types of CCTs and applies also to other designs intended to address multiple research questions.

Click on this LINK to see Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland.


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