JMIR Publications

ABSTRACT

Background:

National Medical Products Administration (NMPA) of China had actively encouraged organizations to adopt CDISC for clinical data submission since 2020. However, the attitude, usage, difficulties, and strategy on CDISC is still unknown in China.

Objective:

This study aims to explore the current status, attitudes, and obstacles to using Clinical Data Interchange Standards Consortium (CDISC) and propose strategies for promoting the application of CDISC in China.

Methods:

A total of 38 experts who served as leaders of data management departments/teams were recruited from 38 institutions in China from April to August 2022. Data on the attitude, usage, and obstacles on CDISC, as well as strategies for its dissemination, were collected using a semi-qualitative questionnaire. For textual data, thematic analysis was conducted using a hybrid approach integrating constructivist and deductive logic, involving iterative coding and theme saturation checks.

Results:

Among 38 participants, 94.7% thought that National Medical Products Administration of China (NMPA) specifying CDISC standards used in submitting data is important for clinical trials, and 84.2% supported. 76.3% had submitted CDISC-compliant data for product registration. The primary barriers to CDISC adoption included high costs, shortage of expertise and training resources, insufficient localization, inherent complexity of CDISC, standard imperfections, lack of detailed regulations/guidelines, low clinical research proficiency, diversity of enterprises/institutes, and survival-related challenges. Corresponding promotion strategies included cost reduction, enhanced publicity & training, implementing CDISC from clinical study design, developing supporting tools, incorporating traditional Chinese medicine terms into CDISC, refining CDISC standards, formulating detailed regulations, establishing a review system, and boosting inter-company/institutional collaboration.

Conclusions:

CDISC has been recognized, adopted and supported by most of data management experts in China. However, key barriers to its promotion remain cost implications, expertise shortages, inadequate technological and socio-environmental policy support. Strategies for CDISC dissemination should prioritize enhancing cost-effectiveness, strengthening publicity and training, and refining regulatory frameworks. Clinical Trial: No applicable.