治験費用の「適正化」と「透明化」 ―Fair Market Value に基づいたベンチマーク型コストについて―

抄録

The “appropriateness” and “transparency” of clinical trial costs in Japan need to be ensured based on the concept of fair market value (FMV). Here, we clarify the mechanism underlying benchmark-based costs and examine the issues that need to be addressed when introducing such a system to sponsors and medical institutions to promote its widespread use. We collected information from IQVIA Services Japan K.K. and Medidata Solutions Inc., the two main global providers of clinical trial cost benchmarking data, regarding the mechanism underlying the collection of cost data, which is the basis of benchmark data, for the provision of services, and provide an overview of the calculation method for clinical trial costs based on benchmark data. Both systems extract and store task-specific cost data for medical examinations, tests, and other tasks in clinical trials. Information is collected from a large number of clinical trial sponsors, and the data are updated periodically to reflect the latest prevailing prices, including the increases in prices and labor costs in each country. Some issues exist in the benchmark data, such as a lack of data on the cost of each service at medical institutions, and differences in the treatment of tests and diagnostic imaging related to expenses not covered by the uninsured combined medical care cost system. As clinical trials using benchmarked costs become more widespread, the reliability of the benchmark data on which the compensation for individual clinical trial tasks is based can be expected to improve.