Drug Evaluation Committee Issues to be resolved to promote the sharing of clinical trial data
Data Science Subcommittee
December 2022
The use of past clinical trial data is considered to be one of the most effective means of transforming the drug development process and making it more efficient. However, the results of a questionnaire conducted by the Data Science Subcommittee 2021 Task Force 2 revealed that many pharmaceutical companies in Japan still do not have an adequate system for sharing clinical trial data, and that data sharing has not progressed as much as expected. This report identifies the causes of the lack of progress in sharing clinical trial data, and provides the necessary information and points to keep in mind in order to address these issues. We believe that this report will be a useful reference for companies that intend to proactively share and utilize clinical trial data in the future.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee 2021 Task Force 2