薬理と治療

Abstract

Background Clinical Trials Act was put into effect in 2018 in Japan, aimed at prevention of scientific misconduct and promotion of clinical research through strict regulation of trial procedures and management of conflict of interest. Critics argue that its overly strict regulations actually disturb clinical trials. Methods Questionnaires were sent to 129 study coordinators/chairmen of “specified” clinical trials, as defined in the Clinical Trials Act, which are subject to strict regulations. The survey included what they think about the paper works associated with the law regulations, the significance of the law, and their prospect on future clinical research. Results　Seventy-seven investigators (59.7%) replied to the survey. Of them, 87% thought the paper works were burdensome, and 73% felt they interfered with their clinical activities. Only 25% and 39%, respectively, thought the law would be helpful to safety of the study subjects and prevention of research fraud. As many as 92% replied that the law would not lead to clinical research promotion; 61% thought it would be counterproductive. In addition, 92% did not think it would be beneficial to future patients, with 59% thought it would be harmful. Only 16% would be willing to work on future clinical trials. Researchers’ perspectives on future clinical research were pessimistic, with 50% predicted dominance of pharmaceutical companies, and another 26% predicted decline of the research itself. Conclusion Current Clinical Trials Act exhaust clinical investigators, who would walk away from clinical trials, leaving only company-sponsored ones to the companies’ interest. Prompt amendment is mandatory.