Blue-button Clinical Trial Matching for Cancer Patients
About Blue-button Clinical Trial Matching
Clinical trials provide cancer patients the opportunity to participate in research and development of new drugs and treatment approaches. Enrollment in cancer clinical trials hinges on patients successfully identifying trials for which they are a match based on their clinical characteristics. Although more than half of all cancer patients agree to participate in a clinical trial when offered, on average only one in four patients will be eligible for a clinical trial available at the institution where they are being seen. This lack of onsite matching trials has been identified as the single largest barrier preventing patients from participating in clinical trials. If no trial is locally available, trial eligibility screening typically involves the use of third-party clinical trial matching services such as ClinicalTrials.gov or various patient advocacy services. These services yield few enrollments because they require significant effort on the part of patients or clinicians (who may not be aware of their existence), and information to match patients to trials may be incomplete.
To address these challenges, the American Cancer Society Cancer Action Network (ACS CAN) has launched development and testing of a new tool, called “Blue-button”, that can automatically identify relevant clinical trials through one-button clinical trial matching integration within electronic health records (EHRs). ACS CAN partnered with MITRE, a not-for-profit organization working in the public interest, through CodeX, one of the HL7® Fast Healthcare Interoperability Resources (FHIR®) Accelerators, to create the tool’s functionality. With just a few clicks in a medical record, the Blue-button tool has the potential to quickly identify comprehensive trial availability within a specified distance from where the patient is located, and by doing so will increase opportunities for patients to maximize access to the latest cancer innovation within their community.
Blue-button Clinical Trial Matching for Cancer Patients Resources
Feasibility of Institution-Agnostic, EHR-Integrated Regional Clinical Trial Matching
Feasibility testing of Blue-button regional clinical trial matching demonstrates that this framework effectively performs trial eligibility screening using limited deidentified patient data and improves trial matching rates because of regional search capability.
Findings from a survey assessing provider needs related to screening for cancer clinical trial eligibility suggest that automated screening tools built into clinical workflows could result in more frequent trial eligibility screening, especially for offsite trials.
Clinical Trial Landscape Report
This comprehensive overview of the barriers faced by patients to enrolling in cancer clinical trials, along with the associated recommendations, was the genesis of the Blue-button matching project.
This report details the size of barriers that prevent patient participation in cancer clinical trials. Lack of onsite trial availability is the single largest barrier to participation.
This paper illustrates high acceptance rates of offers to participate in cancer clinical trials across demographics and drives the hypothesis in this project that offering participation to more patients will result in increased enrollment.
Minimal Common Oncology Data Elements (mCODE)
The mCODE data standard is an oncology-specific non-proprietary data standard developed by ASCO to improve interoperability. The Blue-button integrated matching tool is built using mCODE standards.
Common Oncology Data Elements eXtensions (CodeX)
CodeX is a collaborative community operating as an HL7 FHIR Accelerator to advance FHIR-based interoperability in oncology using the mCODE data standard. The Blue-button integrated matching project is a formally adopted use case of CodeX.
Patient-Facing Clinical Trial Matching Summit and Recommendations
Approximately 50 individuals representing a broad array of stakeholders attended a two-day summit focused on identifying policy and infrastructure recommendations to improve patient-facing cancer clinical trial matching. The summit, held January 31-February 1, 2019, was sponsored by the American Cancer Society (Society) and the American Cancer Society Cancer Action Network (ACS CAN).
Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer
Patient participation is crucial to clinical trial success. Most patients express a willingness to participate in clinical research, yet only a small fraction ultimately end up enrolling in a cancer clinical trial due to barriers that make participation difficult or even impossible. Understanding and addressing these barriers is critical to accelerating progress in cancer research.
In 2022, ACS CAN solicited proposals from sites to host pilot implementation of the Blue-button trial matching tool.
Blue-button source code can be found here.