Drug Evaluation Committee Proposal for a New Clinical Trial Cost Calculation Method Based on Accumulated Work
Clinical Evaluation Subcommittee
March 2009
In January of this year, the "Study Group on the Interim Review of the New 5-Year Plan for the Revitalization of Clinical Trials" compiled a report and recommended that "medical institutions are required to have a payment method based on actual results, a more appropriate calculation method for necessary tasks, and transparency in this method.
Meanwhile, the Clinical Evaluation Subcommittee of the Drug Evaluation Committee, as part of its task force activities in fiscal 2008, studied a new method to replace the current method of calculating clinical trial costs based on a points table, and compiled a proposal in March 2009.
We hope that this proposal will be helpful to medical institutions when they consider a new method for calculating clinical trial costs.
Please note that this proposal is only one of the ideas discussed by the task force and that the adoption of this calculation method has not been approved by individual member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
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