Drug Evaluation Committee Toward Realization of Fair Clinical Trial Costs in Japan (Audio Explanation) Clinical Trial Cost Calculation Process Based on Fair Market Value
Clinical Evaluation Subcommittee
December 2021
We have prepared and released a video with audio Explanation to the material " Toward Realization of Appropriate Clinical Trial Costs in Japan - Clinical Trial Cost Calculation Process Based on Fair Market Value " which was released in May 2019.
With the globalization of clinical trials and the increasing number of global clinical trials, there is a need to ensure "appropriateness" and "transparency" of clinical trial costs based on Fair Market Value. As the complexity and diversity of clinical trial designs continue to increase, and the methods and techniques of conducting clinical trials undergo a period of change, it is becoming increasingly important for sponsors and Investigator Sites to promptly introduce a clinical trial cost calculation process based on Fair Market Value, rather than the conventional method of calculating clinical trial costs based on a point calculation table. It is becoming increasingly important for each sponsor and site to promptly introduce a clinical trial costing process based on Fair Market Value.
It is important for Japan to maintain its international competitiveness in drug development by working together with many sponsors, Investigator Sites, CROs, and SMOs to introduce a clinical trial costing process based on Fair Market Value, and to conform to internationally standardized concepts and rules. We hope that this will help Japan to maintain its international competitiveness in drug development and promote rapid patient access to innovative and highly useful medicines.
Explanation start time for each session
1:31 1. Japan's Approach to Clinical Trial Costs to Date
2:50 2. What is an Appropriate Clinical Trial Cost?
4:14 3. Current status of payment of clinical trial fees in Japan
8:13 4. Current Status of Calculation of Clinical Trial Costs in Japan
12:28 5. For the proper calculation of clinical trial costs
22:16 6. Toward the proper calculation of clinical trial costs in Japan
26:16 7. Final Remarks
The "Toward the Introduction of Milestone Payment to Establish a Performance-Based Clinical Trial Fee Payment Method in Japan (July 2018)" mentioned in this video can be accessed at the link below. Please see also.
https://www.jpma.or.jp/information/evaluation/results/allotment/milestone_payment.html