Values and challenges of running international clinical trials:
Running REMAP-CAP in Japan

On January 19, 2024, we held the 5th Academia Clinical Development Seminar online, inviting Dr. Naoaki Ichihara from Department of Cardiac Surgery, the Jikei University School of Medicine, to speak on “Values and challenges of running international clinical trials: Running REMAP-CAP in Japan”.

First of all, he outlined the REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform Trial for Community Acquired Pneumonia).

He said that REMAP-CAP is a clinical research platform involving 325 sites in 25 countries that aims to rapidly create the clinical evidence needed to make effective treatment decisions in a pandemic.
He also said that REMAP-CAP has played a major role in the corona disaster since late 2019, using an innovative adaptive trial design to efficiently evaluate multiple treatments in clinical settings simultaneously and create clinical evidence on the optimal treatment.

Second of all, he mentioned the following design features of REMAP-CAP.
・Modular protocols based on the core protocol and a clinical trial network that is always in operation, enabling a rapid response to pandemics
・Adoption of a multifactorial design, in which a single subject participates in multiple trials simultaneously
・Adoption of Bayesian statistics to eliminate the risk and waste associated with setting the number of cases

He then explained that REMAP-CAP is an organization built on a sense of equal cooperation, and that the trials are based on a minimal common protocol that complies with ICH-GCP and can be implemented in clinical settings in each country.
Furthermore, he said, the UK has the largest number of sites and cases, and the existing public clinical research support infrastructure called CRN (Clinical Research Network) is being used.

Finally, he summarized that from the perspective of wide-area collaboration, it is important to establish a system that enables understanding of global trends, participation in the research community, and accumulation of know-how from normal times, and that it is necessary to prepare optimal study designs and clinical research systems based on pragmatic ideas to deal with the infectious disease crisis.

In this seminar, he gave us useful information on REMAP-CAP, and the seminar ended successfully with a lively question and answer session.

The next seminar will be held on Friday, February 9, 2024, with Dr. Kazuya Hijii from mk DUO.
We look forward to seeing you at the next meeting.