A case study comparing research integrity, governance and ethics frameworks to facilitate collaboration between Bristol and Kyoto University

Abstract

Researchers and non-commercial institutions negotiate complex legislation and guidance when planning and conducting research studies. The documents and processes required differ across nations and their regulatory bodies and it can be challenging to conduct an international study, especially for non-commercial organisations. In this study, colleagues from Japan and the UK worked closely together focusing on the legislation, organisations, trial processes, ethics review and quality assurance frameworks of clinical trials in two countries, the UK, demonstrated on the model of practices in the University of Bristol and University Hospital Bristol NHS Foundation Trust, and Japan, based on the model in Kyoto University Hospital. Although the ICH tripartite guidelines (ICH-GCP) were developed with participation from both the EU and Japan the set-up and approval processes for clinical trials are different between the two countries while the expectations for quality assurance are similar. We will argue that the framework in the UK is well-developed for performing multi-centre trials both, commercially and non-commercially sponsored. Japan has an excellent infrastructure to conduct early phase trials and commercially sponsored trials. Multi-centre investigator led trials are currently a challenge due to the complex and resource intense approval systems. A good model for collaboration between Bristol and Kyoto might be where early translational studies are set-up in Japan and later phases of the studies are conducted in the UK.