薬理と治療

Abstract

Objectives　The Clinical Trials Act（CTA）was enacted in 2017 and enforced on April 1, 2018, taking the opportunity of inappropriate cases in clinical research that occurred in recent years. With the enforcement of the CTA, pharmaceutical companies provided research funding under appropriate contracts and have been disclosing information on the provided research funds, donations, and rewards on their websites every fiscal year. In addition, the Fair Competition Code related to pharmaceutical companies was revised to in line with the CTA, and regulations related to specified clinical trials was added. As a result, the involvement of companies that provided research funding for specified clinical trials was partially restricted, and companies were required to respond to these restrictions. Following the enforcement of the CTA, the major issues related to clinical research and trial in pharmaceutical companies are:（ 1）decrease in the number of new specified clinical trials（, 2）increase in expenses related to preparation and review of specified clinical trials（, 3）increase in the time require to start specified clinical trials, and（4）differences in where responsibility lies in international joint clinical trials. Pharmaceutical companies have been able to gradually move toward solving issues（1）（, 2）, and（3）, as described below, by responding to these issues with the cooperation and support of related academic societies and academia. However, issue（4）was accompanied by revisions of ministerial ordinances related to the CTA and the Pharmaceuticals and Medical Devices Law, and the situation continued that it could not be solved by the efforts of pharmaceutical companies alone. The Enforcement Regulations of the Pharmaceuticals and Medical Devices Law and the CTA were partially revised in September 2022, and all post‒marking clinical trials can now be implemented under the initiative of companies in accordance with the Pharmaceuticals and Medical Devices Law and GPSP standards. Conclusions　Five years have passed since the CTA was enforced, and the initial issues faced by companies related to the CTA seem to have been resolved with the 2022 amendments to the Pharmaceuticals and Medical Devices Law and the CTA. In addition, the establishment of a dedicated database may solve the problems related to conflict of interest management that investigators have. We expect that by appropriately selecting post‒marketing clinical trial and collaborative clinical research by companies, clinical trials and clinical researches with high social and academic significance will be conducted, and a lot of excellent evidence will be sent out from Japan to the world in the future.（Jpn Pharmacol Ther 2023；51 suppl 2：s51‒56）