Drug Evaluation Committee Establishment of Safety Considerations and Research Questions (Research Questions) for the Implementation of Scientific Drug Risk Management Plans (RMPs) (August 2014)
Data Science Subcommittee
August 2014
The Drug Evaluation Committee's Data Science Subcommittee's 2013 Task Force 1 summarized the establishment of safety considerations and research questions (research questions) for the implementation of a scientific drug risk management plan (RMP).
Now that the RMP is fully implemented, it is important to go beyond the framework of traditional use studies that do not establish comparisons and controls. We believe that risk management of pharmaceuticals should go beyond the framework of conventional use-results studies that do not set up comparisons and controls, and that individual measures should be considered and truly necessary research should be conducted and evaluated.
Conventional drug use-results surveys have many regulatory and implementation problems, but from a scientific perspective, the "research question" is often unclear. Therefore, this task force has been studying the research questions from the perspective of "what is necessary to clarify the research questions" and "how to design research according to individual research questions," based on principles and idealism without being bound by Japan's unique conventions.
This report is intended for those who are in charge of application for approval (those in charge of development, statistics, safety, and implementation of post-marketing surveillance), and presents the ideas necessary to consider individual measures based on safety study issues.
We hope that this report will serve as a milestone toward "kaizen" RMPs.
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