COLLABORATIVE DEVELOPMENT OF CROHN’S DISEASE CLINICAL DATA STANDARDS BY STANDARDS DEVELOPMENT AND CROHN’S DISEASE EXPERTS TO FOSTER DATA REVIEW, SHARING, AND REUSE

Abstract

Abstract Background The ability to access expansive collections of well-curated biological, clinical, and behavioral data will propel scientific progress and enable the discoveries needed to improve treatments for human disease. Development and adoption of standards transform incompatible and disparate data into universal and illuminating information, facilitating discoveries that could have invaluable impact on Crohn’s disease clinical research. When standards are applied, data is collected, organized, and analyzed in a clear and consistent manner, allowing all researchers to leverage information from studies around the world. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. CDISC standards addresses each step of the clinical research process to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market. Methods With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC formed a team of standards development and Crohn’s disease experts to follow our consensus-based, clinical data standards process, which consists of six stages: Scoping – Identification of development topics Concept Modeling – Deep dive understanding of topics Standards Development – Development of standards content Internal Review – Targeted review Public Review – User community review Publication – Freely available on the CDISC website Results The project Standards Development and Internal Review stages completed in September 2020, resulting in the following topics available for the Public Review stage. - 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 Staging (location and phenotypic descriptions of the disease) - Endoscopy Assessments - Cross-section Imaging Assessments (including CT, MRI and Ultrasound) - Histopathology of Biopsy Samples - Biomarkers of Interest for Crohn’s Disease Conclusion To make the greatest impact on Crohn’s disease research, widespread promotion of the availability of the standards for researchers to adopt and implement to their data is of highest importance. CDISC provides complementary education courses and implementation information to assist in this adoption. Widespread adoption of the standards will bring clarity to Crohn’s disease data and will enable the accessibility, interoperability, and reusability of data, driving operational efficiencies, expediting regulatory review, and reducing time to market.