P108 The importance of developing consensus-driven clinical data standards for Crohn’s disease to amplify data
J. Owen, R. Baker
CDISC, Standards Development, Austin, USA
Background
When CDISC standards are applied, data is collected, organised and analysed in a clear and consistent manner so that all researchers can leverage and share information from individuals and studies around the world. Required by the USA Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organisations, CDISC standards enable the accessibility, interoperability, and reusability of data. Adopting CDISC standards is an invaluable investment that leads to more meaningful, more efficient research for your organisation and the entire global research community.
Methods
With support from The Leona M. and Harry B. Helmsley Charitable Trust and following the CDISC consensus-based standards development process, a team of Crohn’s disease and standards development experts was created to develop clinical data standards for Crohn’s disease. The CDISC standards development process consists of five stages:
Scoping
Concept Modelling
Standards Development
Internal Review
Public Review
Publication
Results
The project scoping stage completed in July 2019. The scoping team, consisting of Crohn’s disease clinical SMEs, identified the following topics that would most benefit from development of clinical data standards and to move into the concept modelling and standards development phases of the project:
Package 1
- Questionnaires, Ratings and Scales (including standard symptom measures, patient/investigator reported outcomes, and socio-economic measures)
- Prior and Baseline, and On-Study Treatments (including response to prior treatment)
- Disease Classification (location and phenotypic descriptions of the disease)
- Cross Section Imaging Assessments (including CT, MRI and Ultrasound)
- Histopathology of Biopsy Samples
- Biomarkers of Interest for Crohn’s Disease
The first package of data standards for Crohn’s disease will be available for Public Review in July 2020 and is anticipated to be published in Q1 2021 for use by researchers and industry. The second package of data standards will be available for Public Review in Q3 2020 with publication in Q2 2021.
Conclusion
CDISC’s vision is to encourage the global adoption of standards to leverage and realise the full potential of data and produce faster, more efficient research, paving the way for more breakthroughs in Crohn’s disease treatments, therapies and cures. ECCO attendees and the Crohn’s disease community are encouraged to participate in CDISC’s informational webinars and Public Review stages to foster all-inclusive development, approval and adoption of the data standards.