Infrastructure of pharmaceutical research and development in Japan

To examine the roles of different types of hospitals in implementation of multicenter Phase II/III trials in Japan, specifically focusing on two dichotomies: public versus private, and academic versus nonacademic. Possible explanation was sought as to why a hospital of one category was more likely to participate in specific types of trials in the Japanese medical environment.

A database containing attributes of published clinical trials (n = 217) was established from four journals featuring reports of clinical trial results. The preferences of public and academic hospitals for specific types of trials were estimated by applying a linear regression model. The trial compositions of these institutions were also estimated, taking the actual prevalence of trials in 1995 into consideration.

Public sector hospitals, which were established for particular policy purposes in the national healthcare system, were more likely to accept trials in some fields (e.g., cardiovascular diseases, anesthesiology, antineoplastics, pediatrics) and of some kinds (e.g., Phase II rather than Phase III trials, trials supervised by the principal investigator in the public sector). Academic hospitals also showed preferences for some types of trials (e.g., cardiovascular diseases, dermatology; Phase II rather than Phase III trials). The analysis focusing on public hospitals suggested that policy purposes were achieved at least in some fields such as antineoplastics and anesthesiology.

Japanese clinical trials were unevenly distributed between public and private sectors, and also between academic and nonacademic sectors. These data provide fundamental information about the clinical research environment for future pharmaceutical research and development strategies and policies.