ICH E17 Guideline In summary, strategic use of MRCTs, properly designed and executed according to this guideline, can increase efficiency of drug development, allow for exploration of the treat- ment effect to diverse populations, and enable simultaneous submission of marketing au- thorisation applications and regulatory decision-making in multiple regions. Therefore, MRCTs may generally become the preferred option for investigating a new drug for which regulatory submission is planned in multiple regions. 2.1.2 Good Clinical Practice (GCP) Requirements and MRCTs All sites participating in MRCTs should meet applicable quality, ethical and regulatory standards.
Specifically, MRCTs should be conducted in compliance with ICH E6 GCP standards in all regions and sites, including making sites available for GCP inspections by regulatory authorities. Monitoring plans and other quality checks should be pre-spec- ified and implemented in order to address potential risks to subject rights, safety and well- being, and to the reliability of study results. Centralised and risk-based monitoring may be particularly useful for MRCTs in order to monitor and mitigate the impact of emerging regional differences in, for example, trial subject retention or adverse event reporting (ICH E6).
Timely and accurate flow of information should occur between the sponsor, the trial management team and the participating sites. 2.1.3 Scientific Consultation Meetings with Regulatory Authorities Sponsors of MRCTs are encouraged to have scientific consultation meetings with rele- vant regulatory authorities. These interactions should take place during the planning stage of MRCTs to discuss the regulatory requirements for the overall development plan and the acceptability of MRCT data to support marketing authorisations. Conducting such consultation meetings early in the planning stage of MRCTs will enable the comments received from regulatory authorities to be taken into consideration.
The sponsor should prepare the protocol and other relevant documents, and it may be beneficial to include information as to which authorities are providing regulatory advice, and how that advice is being taken into consideration. Consultation with authorities may happen at various stages affecting different aspects of protocol development. Inter-authority scientific dis- cussions are encouraged to allow for harmonisation of study requirements. 6