Challenges in Using Real-world Clinical Practice Records for Validation of Clinical Trial Data in Inflammatory Bowel Disease: Lessons Learned

• Published in: Inflammatory bowel diseases Vol. 24; no. 1; pp. 2 - 4
• Main Authors: Afzali, Anita, Ciorba, Matthew A, Schwartz, David A, Sharaf, Mai, Fourment, Chris, Ritter, Timothy, Wolf, Douglas C, Shafran, Ira, Randall, Charles W, Kane, Sunanda V
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 01.01.2018
• Subjects: Certolizumab Pegol - therapeutic use; Clinical Trials as Topic; Crohn Disease - drug therapy; Electronic Health Records - statistics & numerical data; Evidence-Based Medicine; Humans; Immunosuppressive Agents - therapeutic use; Patient Care - standards; Practice Management, Medical - organization & administration; Research Design - standards; Retrospective Studies; clinical trials; Crohn's disease; big data clinical trials; electronic medical records; inflammatory bowel disease; Crohn’s disease
• ISSN: 1078-0998; 1536-4844
• DOI: 10.1093/ibd/izx015

Abstract Electronic medical records (EMRs) have gained widespread use in clinical practice and by default serve as a large patient database with potential for use in clinical research. Although there remains significant interest in leveraging EMRs for research purposes, extraction of data has proven to be complex and with insufficient accuracy. We describe the limitations of an EMR in our attempt to conduct a seemingly simple study aimed at validating variables identified in the PRECiSE 3, a 7-year open label safety and efficacy study of certolizumab pegol in Crohn's disease that identified clinical factors that predicted both short- and long-term efficacy. A multicenter, retrospective cohort study from 8 academic and large community practices was performed, and data were collected from each respective EMR. Significant challenges with reliable capture of key data elements were encountered, and overall a screen fail rate of 91.8% across all sites was seen. We describe these challenges and potential future directions to work together to advance accuracy and implementation of the use of EMRs in inflammatory bowel disease.