Therapeutic Research

Abstract

Objectives：To report on the current clinical research situations and attitute around implementation and governance of Pharmaceutical Industries before and after the enforcement of the Clinical Trials Act, by conducting a survey on clinical research at Pharmaceutical Industries to which the members of the Japanese Association of Pharmaceutical Medicine belonged.　　Methods：We conducted two independent questionnaire surveys for pharmaceutical companies Japan before and after the enforcement of the Clinical Trials Act, as of February 2018 and as of July 2020, respectively. A team was set up within the JAPhmed Medical Affairs（MA）Subcommittee to conduct two surveys before and after the implementation of the Clinical Trials Act.　　Results：Total 33 companies in the 1st survey and 32 companies in the 2nd survey responded. Of the 32 Industries responded to the 2nd survey, 17 company（53.1％）indicated that they would prefer to conduct company initiated clinical research under the Japanese Ethical Guidelines, 15 companies（46.9％）indicated that they would prefer to conduct collaborative clinical research under the Clinical Trials Act, and 12 companies （37.5％）indicated that they would prefer to conduct collaborative clinical research under the Japanese Ethical Guidelines. 　　As for the department that will play a central role in generating information in the future, many companies responded that specified clinical research and non‒interventional research under the Clinical Trials Act will be conducted mainly by the MA department, and clinical research support/management will be an important task for the MA department. 　　Conclusions：After the enforcement of the Clinical Trials Act, the currently desirable contractual form of conventional company‒initiated clinical research has increased to include collaborative clinical research and company‒initiated clinical research under the Ethical Guidelines. Many companies consider MA function will play a central role in conducting specified clinical research and non‒interventional research in the future.