国内治験のパフォーマンスとコストに関する調査

摘要

It has been pointed out that (1) trials take longer to conduct in Japan than in the West; (2) the quality of trials is not as high in Japan as in the West; and (3) the cost of conducting trials are higher in Japan than in the West. It has also been discussed that improvement of these 3 factors - speed, quality, and cost requires a robust national policy. R&D Head Club has conducted surveys and analyses of the trial cost and site performance in Japan since 2004. In the present report, data of the past 3 years including 2006 were tabulated and analyzed.A total of 20 pharmaceutical companies participated in this trial cost survey in 2006 : 18 companies belonging to the R&D Head Club, and 2 companies affiliated with Pharmaceutical Research & Manufacturers of America (PhRMA). The survey covered Phase II and III trials that had been completed during a period between April 1 and March 31, and collected information related to protocols, trial sites, payments made to the sites and SMOs, and payments by protocol units.The average number of days between milestones representing the trial speed decreased year after year. The patient enrollment rate was about 70% of the number originally contracted, regardless of the type of site or the time the trial started. The mean number of patients enrolled at clinics was higher as compared with that in other types of sites. Since it is difficult to judge from the change in the surveys whether the study cost per patient tends to increase or decrease, further investigation seems necessary.