Drug Evaluation Committee Study on optimization of costs for medical institutions in clinical trials

Clinical Evaluation Subcommittee

April 2015

The Drug Evaluation Committee's Clinical Evaluation Subcommittee's 2014 Task Force 2 discussed the optimization of medical institution costs in clinical trials. In addition to clarifying the variation in cost calculation by medical institutions in Japan, we investigated cost calculation standards and payment methods in major foreign countries (the United States, the United Kingdom, and Asian countries) to clarify the differences between Japan and other countries. The report also provides suggestions for ensuring international transparency in the calculation and payment of clinical trial costs in Japan. We hope that this document will help you to think about the cost of clinical trials in Japan.

Study on Appropriateness of Medical Institutional Costs for Clinical Trials (1.3MB)

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