Drug Evaluation Committee Issues to be resolved to promote the sharing of clinical trial data
December 2022
Utilizing historical clinical trial data is considered one effective way to transform and streamline the drug development process.However, the results of a survey conducted by Task Force 2 of the Data Science Subcommittee for fiscal year 2021 revealed that many domestic pharmaceutical companies still lack adequately established systems for sharing clinical trial data, and that data sharing has not progressed as much as expected.This report identifies the causes hindering the sharing of clinical trial data and outlines the necessary information and points to consider in addressing these issues. We believe this report will serve as a useful reference for companies seeking to actively share and utilize clinical trial data in the future.
, Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, DS Subcommittee, FY2021 Task Force 2