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

Area of Science:

• Clinical research informatics
• Regulatory science
• Data management in healthcare

Background:

• Clinical Data Interchange Standards Consortium (CDISC) standards are crucial for drug development and mandated in Japan.
• Implementation and challenges of CDISC standards in Japanese academic medical centers remain under-investigated.

Purpose of the Study:

• To comprehensively assess the current status of CDISC standards implementation in Japanese academic medical centers.
• To identify key challenges and opportunities associated with CDISC adoption in this setting.

Main Methods:

• A questionnaire survey was distributed to 91 Japanese academic medical centers.
• The survey collected data on CDISC implementation experience, barriers, resources, and personnel.
• Statistical analysis, including Mann-Whitney U tests, was used to evaluate associations.

Main Results:

• Only 22% of institutions had implemented CDISC standards, with resource shortages being the primary barrier (62%).
• A significant gap exists between the demand for support (66%) and the supply (5%).
• Institutions with implemented CDISC standards had more data managers and biostatisticians (P<.001).

Conclusions:

• CDISC implementation in Japanese academia is hindered by limited resources and personnel.
• Addressing the demand-supply gap for support is a key opportunity for driving adoption.
• Collaboration between academic institutions, pharmaceutical, and contract research organizations can foster nationwide CDISC compliance.