2019 Volume 68 Issue 3 Pages 202-211
Overview of CDISC Standards: Although CDISC (Clinical Data Interchange Standards Consortium) Standards were initially developed as specifications for electronic regulatory submission of new drugs in the United States, they now cover all areas of electronic clinical research data manipulation. Due to regulations of the FDA (Food and Drug Administration) and PMDA (Pharmaceuticals and Medical Devices Agency), CDISC Standards have become popular in pharmaceutical companies all over the world. Academia has the advantage over pharmaceutical companies concerning the application of CDISC Standards to EDC (Electronic Data Capture) and data extraction from EHR (Electronic Health Record), because it is not subject to strict regulatory rules.
Past achievements of Japanese academia concerning CDISC application and current status: Japanese academia actually preceded the United States concerning the actual application of CDISC Standards. For example, UMIN (University hospital Medical Information Network) and Fukushima Medical University succeeded in performing the first actual clinical trial using CDISC-based EDC in the world, and Shizuoka Cancer Center Hospital was the first in the world to extract CDISC ODM (Operational Data Model)-based data from its EHR. In spite of the prior achievements, the application of CDISC Standards for clinical research have not since prevailed in Japan. A specification for electronic exchange of clinical trial data, InterMediate Electronic Standard (IMES), was developed, but it was not promoted internationally in English, and thus could not in any way compete with CDISC Standards as international standard. When it was clear that the adoption of IMES was obsolete, SS-MIX, which was a Japanese local standard developed for healthcare information exchange, came to be used for clinical research data manipulation.
Future applications of CDISC Standards in Japan: It should be emphasized that, if we develop a standard specification, we ought to aim for an international, not local, standard by promoting it to the world and that we should abandon our standard specification if it cannot be an international standard. From this viewpoint, we should strongly promote the application of CDISC Standards for clinical research in Japan. Academic institutions should lead the promotion, using public and other funds.
