Leveraging of open EMR architecture for clinical trial accrual.
Accrual to clinical trials is a major bottleneck in scientific progress in clinical medicine. Many methods for identifying potential subjects and improving accrual have been pursued; few have succeeded, and none have proven generally reproducible or scalable. We leveraged the open architecture of the core clinical data repository of our electronic medical record system to prototype a solution for this problem in a manner consistent with contemporary regulations and research ethics. We piloted the solution with a local investigator-initiated trial for which candidate identification was expected to be difficult. Key results in the eleven months of experience to date include automated screening of 7,296,708 lab results from 69,288 patients, detection of 1,768 screening tests of interest, identification of 70 potential candidates who met all further automated criteria, and accrual of three candidates to the trial. Hypotheses for this disappointing impact on accrual, and directions for future research, are discussed.
Afrin
Lawrence B
LB
Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.
Oates
James C
JC
Boyd
Caroline K
CK
Daniels
Mark S
MS
D002986:Clinical Trials as Topic; D001330:Electronic Data Processing; D032984:Ethics, Research; D006751:Hospital Information Systems; D006801:Humans; D008181:Lupus Nephritis; D016347:Medical Records Systems, Computerized; D018579:Patient Selection / Q000941:ethics; D010865:Pilot Projects