BR&R is the sponsor for this project, but this is a CODEx Project and therefore all the documentation for the project is on the CodeX Confluence pages at Integrated Trial Matching for Cancer Patients and Providers
- Most cancer patients who enroll in clinical trials learn of these opportunities from their providers or from study staff, but most hospitals do not run trials.
- Existing patient-facing tools for clinical trial matching typically require a challenging amount of manual clinical data entry and / or manual review of trials.
- Providers do not have tools built in their workflow to allow for efficient clinical trial matching. As a result, providers often have to use the same patient-facing tools and manually enter data and / or manually review trials.
- A cancer patient identifies clinical trials for which she may be eligible. She uses tools that she can access directly, and she does not have to do manual transcription of clinical data. Rather, the patient facing matching tools leverage structured patient data from the electronic health record (EHR) to assess clinical trial eligibility.
- A provider identifies clinical trials for which her patient may be eligible. She uses tools that she can access directly in her workflow and does not have to do manual transcription of clinical data. Rather, there is a tool built into the EHR system that allows the provider to send structured patient data straight from the EHR to a matching service to assess potential matches.
- Develop open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching services
- Drive awareness of and commitment to use these standards in the industry
- Thereby improve clinical trial matching for patients and their care team.
Project Scope Statement - PSS-1686 - Getting issue details... STATUS
This project is dependent on the mCODE Implementation Guide - http://hl7.org/fhir/us/mcode/
Documentation and an implementation guide will be created to guide matching services in becoming “mCODE-enabled”. This means the clinical trial matching service can receive mCODE records and analyze the records to make matches. Patients and providers will be able to send mCODE records to mCODE-enabled matching services and view the matches in tools they already use (patient data manager applications, EHRs, etc.).
Due to the complexity of clinical trial eligibility criteria, we are focusing on only the most important eligibility criteria in clinical trial matching, which we call our "optimized patient data elements" (OPDE). Our mCODE-enabled matching services will only be analyzing this list of OPDE - not the full patient record. While perfect matches won’t be found by using only the OPDE, the number of clinical trials a patient may match to will be filtered down to a manageable amount for the patient and provider to then manually review. The current list of OPDE includes: cancer type, cancer-subtype, age, biomarker status, stage, presence of metastasis, performance status, and past treatments. This list is being studied and refined.
Status: (active, on-hold, inactive, completed)
Draft implementation guide - http://build.fhir.org/ig/standardhealth/fsh-pct/index.html
Last updated date: The Integrated Trial Matching for Cancer Patients and Providers project team meets weekly on Friday at 12:30pm ET. The weekly call minutes are available here - Trial Matching Meetings. If you'd like to join, please contact Caroline Potteiger (firstname.lastname@example.org).
FHIR Resources in use
ResearchStudy, Bundle, Patient, Condition, Observation, MedicationStatement, Procedure