Drug Evaluation Committee How medical institutions should be in view of changes in the clinical trial environment 16 Key Points for Clinical Trial Sponsors (September 2018)
Clinical Evaluation Subcommittee
September 2018
In order for medical institutions to adapt to changes in the clinical trial environment, such as the domestic regulation of ICH-E6 (R2), the enforcement of the Clinical Research Act, and intensifying international competition, it is considered necessary to make improvements toward the establishment and operation of an autonomous clinical trial implementation system. Therefore, the 2017 Clinical Evaluation Subcommittee TF-4 summarized 16 key points considered necessary for autonomous medical institutions from six perspectives: education, roles, staffing, systems, results, and climate, from the perspective of the sponsor of the clinical trial. In addition, for each of the 16 key points, examples of improvements actually implemented at medical institutions and past results reported by the Pharmaceutical Manufacturers Association of Japan (PMAJ) are also introduced to provide a trigger for improvement. Slides are also available for use by medical institutions, and we hope that they will be of assistance in their improvement activities. We hope that sponsors will use this document not only to promote their own reforms, but also to promote collaboration for the improvement of medical institutions.
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