2020 Volume 10 Issue 3 Pages 169-174
Regulatory authorities in Japan and US, i. e., PMDA and FDA, have mandated the submission of electronic data according to CDISC standards at the time of new drug application. That has had a major impact on the Japanese pharmaceutical industry. The world-wide data standards for clinical trial data, i. e., CDISC, should bring significant benefits for us, i. e., 1) reusability, 2) interoperability, and 3) an ability to integrate data from different sources and obtain a knowledge beyond a single clinical trial. However, the industry has not fully reaped such benefits. This is mainly because currently we are spending a lot of resources on converting data from completed clinical trials, which did not comply with CDISC standards, into CDISC-compliant data. We should move away from the data conversion just before the new drug application and hasten the end-to-end implementation of the CDISC standard. What we, the pharmaceutical companies, expect from PMDA is that PMDA will conduct many regulatory science studies, which is possible only with accumulated data, and that PMDA will continue to provide feedback to companies and researchers who are developing drugs, and that PMDA will continue to disseminate useful information to the world.
