Drug Evaluation Committee Utilization and Considerations for Open Source Software" and "OSS Usage Questionnaire Report
April 2023
In recent years, the use of open-source software (OSS), such as R and Python, has become increasingly widespread in the field of clinical development.
This task force conducted a survey to assess the use of open-source software in the clinical development operations of companies belonging to the Data Science Subcommittee and compiled the results into the “OSS Usage Survey Report.”
Additionally, in the document titled “Utilization of Open-Source Software and Points to Note,” we introduce open-source software, outline its advantages and precautions for use, and—using R as a case study—describe the management systems and training content that would likely be necessary if open-source software were to be used in regulatory submission processes.
We hope this report will be helpful in your consideration of using open-source software, particularly R, within your organization.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, Data Science Subcommittee, FY2022 Continuing Task Force 5