Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation April 2019
April 2019
In March 2015, the Clinical Evaluation Subcommittee of the Drug Evaluation Committee compiled two papers containing recommendations regarding new legal regulations for clinical research and a new clinical trial system. Furthermore, upon the enforcement of the Clinical Research Act in April 2018, the subcommittee published an editorial outlining expectations and challenges related to the new law.
Recently, the Clinical Research Subteam of Task Force 1 for Ongoing Issues in fiscal year 2018 compiled a new paper examining the impact of the Clinical Research Act on pharmaceutical companies. This paper is based on the results of a survey conducted within the Clinical Evaluation Subcommittee regarding the status of clinical trials voluntarily planned and conducted by pharmaceutical companies after product approval.
The Clinical Evaluation Subcommittee plans to continue its deliberations on the effective utilization of evidence derived from clinical research.