A comparative analysis of content requirements for clinical trials protocols in international regulatory documents

Abstract

Aim to review the international regulatory documents on the requirements for the content of the protocol as the main document of a clinical trial. Material and methods. The ICH GCP, the EU Directive 536/2014, the Order 200n, the Rules of Good Clinical Practice of the EAEU and the FDA documents were reviewed. The analysis followed the 46 points of section 6 of ICH GCP E6 (R2). Results. As a result, 40 of the 46 points, considering the protocols content requirements, in all analyzed documents were similar. The essential differences were found in the Directive EU 236/2014. Firstly, the 6 points of the requirements were lacking; secondly, it contained points that were not reflected in any of the other 4 documents. Conclusion. The Directive EU 236/2016 obliges the protocol developers to employ a more detailed and qualitative approach to the protocol creation and prescribes to provide a more detailed description of certain measures and information about drugs. The Directive EU 236/2016 is not interchangeable with the 4 regulatory documents mentioned above. Sponsors need to more carefully analyze the possibility of conducting clinical trials in the Russian Federation according to the protocols developed in the EU, paying attention to the additional points of the local requirements.