CodeX Integrated Trial Matching for Cancer Patients and Providers

Presently, there are a number of barriers for patient participation in clinical trials. Matching patients with trials require a challenging amount of manual entry and / or manual review of trials and frequently this is not integrated into existing clinical workflows. As a result, patients eligible to participate in a clinical trial may not be identified or asked to enroll. Secondly, many patients do not have a local trial available for their cancer at the institution where they are being seen, and providers do not have means to easily identify trials for their patients that are conducted outside the treating healthcare institution. Consequently, only about 27% of cancer patients will have the option to enroll in a local clinical trial at the institution they are being treated at. Furthermore, approximately 20% of cancer clinical trials fail due to insufficient patient enrollment.   To help fix this problem, the CodeX team aims to develop open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching services. The goal of this project is to utilize the mCODE standard to send structured, patient data directly from the EHR or patient data manager system to trial matching services. Then, the patient data can be analyzed for potential matches and can be presented back to the patient or provider, eliminating the need for manual data entry. The team has decided to take a multi-phased approach to demonstrate the value of mCODE-enabled, interoperable matching services to empower patients and their providers to identify clinical trials. The first phase includes creating a proof of concept that demonstrates the ability of a trial matching service to receive an mCODE record, analyze the record to make matches, and then present the matches back to the patient or provider. After the proof-of-concept, the second phase includes a retrospective study in which past patient records are sent to multiple mCODE-enabled matching services to determine if matches that would be found in a manual search are still found in the mCODE-enabled automated search. Finally, the third phase includes a prospective study in which current patient records are sent to multiple mCODE-enabled matching services and the improved ease and efficiency of finding clinical trials for patients can be demonstrated.   Work products will include a Reference Implementation describing how patient portals and clinical trial matching services can become mCODE enabled and and a new FHIR IG based off of mCODE to accommodate the patient data needed for clinical trial eligibility criteria.   For more information, please see: http://hl7.org/fhir/us/mcode/ https://confluence.hl7.org/display/COD/CodeX+Home https://confluence.hl7.org/display/COD/Integrated+Trial+Matching+for+Cancer+Patients+and+Providers