Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From...

Area of Science:

• Health Data Science
• Clinical Research Informatics
• Regulatory Science

Background:

• Real-world data (RWD) and real-world evidence (RWE) are vital for clinical research and healthcare decisions.
• Standardized, semantically interoperable data are essential for generating reliable RWE.
• Clinical Data Interchange Standards Consortium (CDISC) standards are globally recognized and used in pharmaceutical regulatory submissions.

Purpose of the Study:

• To identify barriers hindering the implementation of CDISC standards for RWD.
• To determine necessary tools and guidance for easier CDISC standard implementation in RWD.

Main Methods:

• A qualitative Delphi survey was conducted.
• An expert advisory board with diverse stakeholders provided input over three rounds.

Main Results:

• 66 experts participated in the initial round, with 49 completing the final round.
• Widespread agreement on the necessity of RWD standardization for data sharing and RWE quality.
• Priorities include electronic health records (e.g., FHIR) and observational study data, with a need for gap analysis and collaboration.

Conclusions:

• CDISC standards are successful for clinical trial data but complex for RWD due to purpose mismatch and implementation challenges.
• Barriers include complexity, lack of awareness, insufficient training, and inadequate support.
• Moving forward requires use cases, development of RWD-specific tools, and collaboration with other standards organizations.