What is a Complex Clinical Trial?

In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials, a new Q&A document covering this topic has now been published on the European Commission (EC) website. The document contains various questions and answers and is intended to serve as support on both scientific aspects and from planning to interpretation of complex clinical trials under the EU Clinical Trials Regulation (CTR). It complements the relevant EU and ICH guidelines and should be used in conjunction with them.

Complex Clinical Trials (CCT) - Questions & Answers

CCT-Definition: According to the Q&A document CCTs 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". CCTs can also include ATMPs as IMPs.

The nomenclature in the Q&A document follows the EU CTR, relevant ICH guidance, the Clinical Trials Facilitation and Coordination Group (CTFG) Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials and international common use as appropriate. Additional non-binding terminology is described in a glossary.

Areas covered in the guidance include:

• Planning and conducting complex clinical trials
• Design and preparation of master protocols
• Methods for clinical trial analysis
• Biomarkers and their testing
• Reporting of study information to regulatory authorities
• Transparency

Further details can be found in the Guidance on the EC website in Questions and answers - Complex clinical trials.