JMIR Publications

ABSTRACT

Background:

The implementation of Clinical Data Interchange Standards Consortium (CDISC) standards is crucial for accelerating clinical research. In Japan, the Pharmaceuticals and Medical Devices Agency has mandated the use of these standards for new drug marketing approval applications, and the Japan Agency for Medical Research and Development promotes their adoption in academia-led research.

Objective:

This study aimed to clarify the current status of and challenges associated with the implementation of CDISC standards in Japanese academic medical centers.

Methods:

A questionnaire survey targeting 91 institutions—83 university hospitals (43 national, 8 public, 31 private, and 1 ministry-affiliated university hospital), seven National Centers for Advanced and Specialized Medical Care, and one National Hospital Organization—was conducted from June 12 to August 16, 2024.

Results:

Responses were obtained from 84 of the 91 targeted institutions (response rate: 92%). Among all 91 institutions, 29% had experience with contracted CDISC standards data creation, and 22% had implemented CDISC standards. The most frequently cited barrier to CDISC standards implementation was “significant human and financial effort and resource shortages” (62%). Meanwhile, many institutions expressed a need for support, with 58% requesting materials and information on CDISC, 49% workshops, and 36% on-the-job training. Overall, 66% of institutions desired at least one of these forms of assistance. Furthermore, 66% of institutions had not yet decided on their future policy for creating CDISC standards-compliant data.

Conclusions:

The implementation of CDISC standards in Japanese academia is limited, with human and financial burdens and resource shortages posing significant barriers. However, the results of the present survey indicate that many institutions are interested in implementing CDISC standards and require support such as workshops and the provision of materials. Providing such support is expected to promote the implementation of CDISC standards in the future. Clinical Trial: Not applicable. This study does not involve a clinical trial.