2025 Volume 30 Pages 117-125
Background Although Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly adopted in the pharmaceutical industry, where submission of compliant data is required for New Drug Applications, their adoption in academia remains limited because of the lack of regulatory requirements. Nevertheless, 53 self-motivated academic participants voluntarily gathered, demonstrating significant interest despite not having implemented the standards. This study aimed to identify barriers to adoption and explore what is needed to support CDISC implementation in academic settings.
Methods A questionnaire was distributed via Google Forms and sent via email to members who are currently contactable by the group leader. Responses were collected and analyzed using Gemma 2 to extract the key issues and propose solutions, with subsequent researchers reviewing the results.
Results Twenty-nine responses were obtained. Analysis identified three key challenges: (1) lack of knowledge regarding CDISC standards coupled with insufficient time for learning; (2) difficulty applying the standards in practice; and (3) limited access to expert guidance. Suggested measures include securing dedicated learning time, raising institutional awareness, developing stepwise educational materials, and establishing networks for collaboration and knowledge sharing.
Conclusions These findings validate previous observations regarding CDISC adoption challenges in academia. Importantly, these data-driven insights strengthen previously anecdotal understanding with evidence. New perspectives emerged, particularly regarding practical application difficulties and the critical role of expert interaction. Based on these findings, targeted educational resources and collaborative networks will likely promote the adoption of CDISC standards across academic research environments.
