2018 年 49 巻 6 号 p. 213-218
Although the Japanese government has been promoting academia-industry collaboration since the 1990s, inappropriate relationship between some companies and researchers has become a problem. The government has issued the guidance for conflict of interest (COI) management, which will need to be revised as per the current situation in the hospitals. The objective of this study was to examine the current situation of COI management structure in Japanese hospitals that may be involved in multi-center clinical trials. We sent questionnaires on topics relevant to COI management to 590 hospitals. Among the 190 respondents (response rate＝32%), 100 hospitals had independent COI management committees. The committees had an average of 7 members, including one external member. In 76 hospitals, the secretariat of COI management committee was placed in the administration and management department. In the previous year, 48 committees collected additional information from researchers through interviews and 35 committees provided advice. Our survey showed wide diversity among hospitals regarding management standards and activities of independent COI management committees. However, they shared a common point in that the COI management committees do not function actively. Although the Clinical Trials Act has provided a standardized COI management strategy, further studies are required to develop more practical guidelines for COI management in clinical trials.
