Washington, D.C. and Ann Arbor, Mich. —The American Cancer Society Cancer Action Network (ACS CAN) and the HL7 FHIR Accelerator™ Common Oncology Data Elements eXtensions (CodeX) are working together with partners on a project to increase and expand patient enrollment in cancer clinical trials at smaller and non-research oriented medical centers. The project will integrate cancer clinical trial matching capability into existing electronic health record (EHR) and patient data management (PDM) systems using open data standards and application programming interfaces (APIs).
Among the many barriers to clinical trial participation is finding potential trials for patients to consider. Matching patients with trials requires providers to do extensive manual data entry and carefully review indepth criteria. While large academic centers often have infrastructure and resources to screen patients for onsite trials, they typically do not screen patients for offsite trial eligibity. Smaller non-research-oriented centers also do not screen for offsite trial eligibility and do not offer onsite trials. Consequently, only about one in four cancer patients will have the option to enroll in a clinical trial at their institution.
The Integrated Trial Matching Project will provide basic trial screening using existing tools within EHR and PDM systems. The matching occurs by sending a select number of standardized patient data points to external clinical trial matching services that then return the results for any matching trials within the region.
Partner groups during the pilot phase include the MITRE Corporation, TrialScope, Massive Bio, BreastCancerTrials.org, Cancer Insights, TrialJectory, PatientLink, and University of Texas Southwestern. There are ongoing efforts to expand partners.
“In order to be successful, cancer clinical trials must have a diverse pool of participants. Yet a lot of patients who would be eligible to enroll and are interested are never given the chance simply because they’re being treated at smaller, community-based oncology clinics that may not have a research infrastructure,” said Mark Fleury, policy principal for ACS CAN. “If we make it quick and easy for these providers to locate potential trials for their patients—without creating additional steps or systems—we could increase and expand trial enrollment to many more people.”
The CodeX initiative, a collaborative effort implementing oncology data standards to support better, safer, faster care, and lower burden and cost, is helping implement the project.
“Several years ago, MITRE began engaging partners from across the oncology ecosystem who also understood the power of data standards and interoperability to improving cancer care and research for all. Today CodeX members are combining the mCODE™ (minimal Common Oncology Data Elements) data standard and HL7® FHIR® (Fast Healthcare Interoperability Resources) technology to solve some of the most challenging problems —including helping cancer patients find clinical trials in a more efficient and equitable way,” said Steve Bratt, Program Manager for the CodeX HL7 FHIR Accelerator.
The project has multiple phases. Use case development and data exchange protocols have been completed and small scale pilots are currently underway. The results will inform a large-scale study planned for this summer to measure the tool’s effectiveness, as well as its usability for both providers and patients.