Current Status, Challenges, and Opportunities Associated With Implementing Clinical Data Interchange Standards...

The implementation of Clinical Data Interchange Standards Consortium (CDISC) standards is essential for accelerating clinical research and is mandated for new drug applications in Japan. However, the current status of their implementation and associated challenges in Japanese academic medical centers has not been comprehensively investigated.

This study aimed to comprehensively clarify the current status, challenges, and opportunities associated with implementing CDISC standards in Japanese academic medical centers.

We conducted a questionnaire survey targeting 91 academic medical centers (83 university hospitals, 7 national centers for advanced and specialized medical care, and 1 national hospital organization) from June to August 2024. The survey assessed experience with contracted CDISC data creation, implementation status, barriers, and available resources. We performed Mann-Whitney U tests to assess the association between the number of data managers or biostatisticians and CDISC implementation status.

Responses were received from 84 institutions (response rate: 92%). While 29% (26/91) had experience with contracted CDISC standards data creation, 22% (20/91) had implemented CDISC standards. The most frequently cited barrier to CDISC standards implementation was "significant human and financial effort and resource shortages" (62%, 56/91). A significant "supply and demand" gap was identified: while 66% (60/91) of institutions expected support (eg, materials, workshops) from other organizations, only 5% (5/91) were capable of providing such resources. Furthermore, 66% (60/91) of institutions had not yet decided on a future policy regarding CDISC compliance. Notably, institutions that had implemented CDISC standards had significantly higher numbers of data managers (P<.001) and biostatisticians (P<.001) compared to those that had not.

The implementation of CDISC standards in Japanese academia is limited, primarily due to resource shortages and a lack of specialized personnel. However, the discrepancy between the high demand for support and limited supply highlights a significant opportunity. Experienced academic research organizations, in cooperation with pharmaceutical companies and contract research organizations, can drive nationwide adoption by taking a strategic leadership role in providing educational resources and training, thereby addressing the critical shortage of specialized personnel and know-how.