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Phase 0 Overview:

Goal:

  • The goal of Phase 0 was to demonstrate the ability of a trial matching service to receive an mCODE record, analyze the record to make matches, and then present the matches back in a standardized way. 


Key Outputs: 

  • Standards and documentation for trial matching services to become mCODE-enabled 
  • Proof-of-concept patient facing user-interface 
  • mCODE-enabled trial matching service 


Process: 

  • mCODE patient data was sent to an mCODE-enabled trial matching service, the record was analyzed for matches, and the results were presented back in a standardized fashion. 
  • The trial matching service, TrialScope, was "mCODE-enabled". This means that the data model TrialScope uses to match patients to clinical trials was mapped to mCODE. As a result, TrialScope is now able to receive mCODE records and analyze the record to make matches. 
    • A service wrapper was developed. This is where the data translation to the matching query and a mapping of the matching query results to a FHIR ResearchStudy. 
    • Trial matching services have to fill out the template with the proper pulling of the data from the bundle that contains patient data and a FHIR Parameters resource. Additionally, mapping will be needed of the results returned from the trial matching service to a ResearchStudy. 
    • The service wrapper template is only necessary if the trial matching service doesn't want to write their data translation from scratch. 
  • A patient facing user interface was developed to display the results. 
    • Currently, we are using an Angular SMART on FHIR web app. 
  • Only the optimized patient data elements were tested - cancer type, cancer sub-type, stage, biomarkers, treatments, age.
  • Synthetic patient data (mCODE Test Data) was used for this initial proof-of-concept. 
  • The initial scope for Phase 0 was breast cancer patients and breast cancer clinical trials. 


Results:

This table describes the results from Phase 0 and how they relate to the initial success measures and outputs created during Phase 0 planning. 


Success Measure/OutputTitleDescription Link
Open Source Proof-of-Concept Implementation Draft Implementation Guide A draft implementation guide with background on this project, how the optimized patient data elements map to mCODE, and resources used by the clinical trial matching service. http://build.fhir.org/ig/standardhealth/fsh-pct/index.html 
Open Source Proof-of-Concept Implementation GitHub Code Repository for the User Interface This is a SMART on FHIR (SMART on FHIR documentation) application that is used for a standard way of sending relevant patient data for clinical trials and returning the results uniformly. The goal of this application is provide an easy to use interface for connecting clinical trial matching services.https://github.com/mcode/clinical-trial-matching-engine
Open Source Proof-of-Concept Implementation Generic Backend Library for Trial Matching ServicesProvides a generic backend library for Clinical Trial Matching Service implementations. This provides the generic shell for services that connect to an actual clinical trial matching service. It receives a FHIR Bundle of patient information, and then uses that to generate a FHIR search result that contains FHIR ResearchStudy objects that describe matching clinical trials.https://github.com/mcode/clinical-trial-matching-service
Open Source Proof-of-Concept Implementation Trial Matching Service Wrapper Template 

Template which streamlines the process of writing a server for clinical trial matching system.

https://github.com/mcode/clinical-trial-matching-service-template

mCODE Matching Service API  


Ability for matching services to implement this capability 

TrialScope Wrapper 

Backend service that calls TrialScope's API for the front-end clinical-trial-matching-engine.

https://github.com/mcode/clinical-trial-matching-service-trialscope/releases/tag/phase-0

mCODE Matching Service API 


Ability for matching services to implement this capability 

BreastCancerTrials.org Wrapper 

Wrapper for sending queries to the breastcancertrials.org clinical trial search service.

https://github.com/mcode/clinical-trial-matching-service-breastcancertrials.org/releases/tag/phase-0
Open Source Proof-of-Concept Implementation How Trial Matching Services Can Become mCODE-EnabledDocumentation describing the steps trial matching services need to take in order to become mCODE-enabled. 

Standardized Match Outputs/Results 


Ability for matching services to implement this capability 

Demonstration  

Video demonstration of Phase 0. 

Standardized Match Outputs/ResultsPublic Presentation on Phase 0Slides used for a public call held on September 16th, 2020 that focused on background of this use case and results from Phase 0. 


Partners:

  • Co-champion - American Cancer Society Cancer Action Network 
  • Co-champion - The MITRE Corporation 
  • Matching Service - TrialScope 
  • Matching Service - BreastCancerTrials.org
  • Patient Portal - Cancer Insights 
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