Knowledge, Attitudes, Practices, Barriers, and Promotional Strategies Related to Clinical Data Interchange Standards...

National Medical Products Administration of China has actively encouraged organizations to adopt the Clinical Data Interchange Standards Consortium (CDISC) for clinical data submission since 2020.

This study aimed to explore the knowledge, attitudes, practices, and barriers to using the CDISC among data managers and to propose strategies for promoting CDISC use in China.

A total of 38 participants as leaders or experts of data management departments and teams were recruited from 38 organizations in China from April to August 2022. Data on knowledge, attitude, practice, and barriers to the CDISC, as well as strategies for its dissemination, were collected using a semiqualitative interview guide. For textual data, thematic analysis was conducted using a hybrid approach integrating constructivist and deductive logic, involving iterative coding and theme saturation checks.

Of the 38 participants, 36 (94.7%) mentioned that the National Medical Products Administration of China specifying CDISC standards used in submitting data is important for clinical trials, 32 (84.2%) supported this policy, and 29 (76.3%) had experience with CDISC-compliant submissions. The primary barriers to CDISC implementation included high costs, shortage of specialized expertise and training resources, inadequate localization support, inherent complexity of CDISC standards, incomplete standard specifications, lack of detailed regulatory guidelines, low overall proficiency in clinical research, heterogeneity among enterprises and institutions, and challenges related to organizational survival. Corresponding promotional strategies included cost reduction, strengthened publicity and training, adoption of the CDISC from clinical study design, development of supporting tools, integration of traditional Chinese medicine terminology into the CDISC, refinement of CDISC standards, formulation of detailed regulatory guidelines, establishment of a review system, and promotion of collaboration among enterprises and institutions.

The CDISC has been recognized, adopted, and supported by most data management experts in China. However, key barriers to its widespread implementation continue to include cost burdens, expertise shortages, and inadequate technological, social, and policy support. Strategies to advance CDISC dissemination should prioritize improving cost-effectiveness, strengthening outreach and training, and refining regulatory frameworks. These findings provide valuable references for international regulators and sponsors in advancing the global adoption of the CDISC.