Drug Evaluation Committee Utilization and Considerations for Open Source Software" and "OSS Usage Questionnaire Report
Data Science Subcommittee
April 2023
In recent years, the use of open source software (OSS) such as R and Python has become increasingly active in the field of clinical development.
This task force conducted a questionnaire to understand the use of open source software in the clinical development work of member companies of the Data Science Division, and compiled it into the "OSS Usage Status Questionnaire Report.
In addition, as "Utilization of Open Source Software and Points to Consider," we introduced open source software, its advantages, and points to note when using it, as well as the management system and education and training that are considered necessary when assuming the use of open source software for approval application work, using R as a case study.
We hope this report will help you consider the use of open source software, especially R, in your company.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee FY2022 Ongoing Task Force 5