Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation April 2019
Data Science Subcommittee
April 2019
In March 2015, the Clinical Evaluation Subcommittee of the Drug Evaluation Committee compiled recommendations on new laws and regulations for clinical research and new clinical trial systems in two papers, and furthermore, when the Clinical Research Act went into effect in April 2018, the Subcommittee compiled an editorial on the expectations and challenges of the new law in the form of a paper.
The Clinical Research Subteam of the 2018 Ongoing Issues Response Team-1 has now 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 that are voluntarily planned and drafted by pharmaceutical companies after approval.
The Clinical Evaluation Subcommittee plans to continue to study the effective use of evidence from clinical research.
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