Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation March 2018
Clinical Evaluation Subcommittee
March 2018
In March 2015, the Clinical Evaluation Subcommittee of the Committee on Drug Evaluation published two papers with recommendations for new legislation and regulations for clinical research and a new clinical trials system.
The Clinical Research Subteam of KT-1, a continuing issue for FY 2017, has now prepared a new paper, an editorial on the expectations and challenges of the new law as the Clinical Research Act comes into effect in April 2018. This paper is based on information available through the end of January 2018 (after the end of the public comment period) regarding the draft regulations for implementing the Clinical Research Act, which were compiled after deliberations from August to November 2017 by the Clinical Research Subcommittee of the Health Sciences Council.
The Clinical Evaluation Subcommittee plans to continue to study the effective use of evidence from clinical research.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables