| Title: |
Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey |
| Authors: |
Rhonda Facile; Erin Elizabeth Muhlbradt; Mengchun Gong; Qingna Li; Vaishali Popat; Frank Pétavy; Ronald Cornet; Yaoping Ruan; Daisuke Koide; Toshiki I Saito; Sam Hume; Frank Rockhold; Wenjun Bao; Sue Dubman; Barbara Jauregui Wurst |
| Source: |
JMIR Medical Informatics, Vol 10, Iss 1, p e30363 (2022) |
| Publisher Information: |
JMIR Publications |
| Publication Year: |
2022 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
Computer applications to medicine. Medical informatics; R858-859.7 |
| Description: |
BackgroundReal-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them. ObjectiveThe aim of this study is to understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance that may be needed to implement CDISC standards more easily for this purpose. MethodsWe conducted a qualitative Delphi survey involving an expert advisory board with multiple key stakeholders, with 3 rounds of input and review. ResultsOverall, 66 experts participated in round 1, 56 in round 2, and 49 in round 3 of the Delphi survey. Their inputs were collected and analyzed, culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data sharing and the quality of RWE. The priorities for RWD standardization included electronic health records, such as data shared using Health Level 7 Fast Health care Interoperability Resources (FHIR), and the data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify the areas where synergies and efficiencies are possible and then collaborate with stakeholders to create or extend existing mappings between CDISC and ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://medinform.jmir.org/2022/1/e30363; https://doaj.org/toc/2291-9694; https://doaj.org/article/739479ad186542a19d67659024b41502 |
| DOI: |
10.2196/30363 |
| Availability: |
https://doi.org/10.2196/30363; https://doaj.org/article/739479ad186542a19d67659024b41502 |
| Accession Number: |
edsbas.33A91B57 |
| Database: |
BASE |