Guest blog contributed by Rikimaru Nishimura, Statistical Programming, Janssen Pharmaceutical K.K.

I would like to introduce the task force of Open-Source Software (OSS) in Data Science Expert Committee, Drug Evaluation Committee of Japan Pharmaceutical Manufacturers Association (JPMA), which is one of the R activities in Japan.

This task force has started its activities since 2022 and currently consists of 10 members from pharmaceutical companies. The purpose of this task force is to investigate the use of OSS which is being more actively used in the pharmaceutical industry, especially for the analysis of clinical trial data and work related to regulatory submission, and to compile and publish a report on the expected benefits and issues when OSS is used.

The document titled “Utilization and Considerations for Open-Source Software” was released by JPMA last year. In the document, current activities related to R in the pharmaceutical industry, the challenges of using R for regulatory submission, package versions and operation managements, and examples of R training are introduced.

In addition, a survey report on the actual use of R in pharmaceutical companies has also been released. Survey results show that more than half of pharmaceutical companies in Japan are already using R and half of the companies have already submitted documents generated by R to regulatory authorities. On the other hand, the task force found that many companies have concerns about using R, such as reliability of open-sourced packages.

There are also challenges in using R for submission. PMDA does not require the use of specific software for the data management and analysis of clinical trial data for the purpose of the submission. Therefore, the choice of software to be used is left to the applicant, and there is no problem in using R for the purpose of submission. However, it is necessary for the applicant to conduct verification work to ensure the quality of the software (reliability of analysis results) and document the procedures and results.

The main theme of this year’s task force is to collect and publish examples of R and Python utilization in the pharmaceutical companies in Japan. The task force is planning to investigate examples of OSS utilization in clinical development and share the introduction procedures, usage environment, software including packages, and utilization effects. The task force will also continue to consider the use of R for submission same as last year.

Finally, I believe that the use of R will become even more active in the pharmaceutical industry in Japan. I will continue to work closely and actively with the R consortium and other external organizations to contribute to the increased use of R throughout the pharmaceutical industry.

About the Author

Rikimaru Nishimura has worked as a Statistical Programmer for Janssen Pharmaceutical K.K. since February 2015. He is responsible for statistical analysis in clinical trials and e-Data submission to PMDA. Before working in the pharmaceutical industry, he has experience developing bank accounting and customer management systems in Japanese technology company. Also, he is a start-up member of the open-source software task force in Japan Pharmaceutical Manufacturers Association.

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