ICAREdata Project Overview  

The ICAREdata (Integrating Clinical Trials and Real-World Endpoints) Project is the trailblazing pilot of the CodeX EHR Endpoints for Clinical Trials use case.

Problem: 

  • Clinical care of cancer patients requires data to identify and understand therapies - understanding treatment responses requires longitudinal analysis of multiple sequential therapies
  • Clinical trials are the gold standard for clinical care interventions – only 8% of cancer patients in the U.S. enroll in clinical trials
  • Currently, data collected prospectively in the EHR is not sufficiently high quality - lack of data standardization has led to significant variations in data and the inability to collect data longitudinally across organizations

Approach:

  • Partner with Alliance and AFT clinical trials to collect and test ICAREdata outcome data based on mCODE
  • Use ICAREdata method, leveraging mCODE, to collect key outcome data which in the past were not typically collected in the EHR in a structured way
    • Cancer Disease Status
    • Cancer Treatment Plan Change
  • Compare these EHR data to those obtained through traditional clinical trial data capture methods
  • Serve as a pilot for clinical oncology research
    • Partner with select National Clinical Trials Network (NCTN) institutions to collect outcome data for patients enrolled in the clinical trials within the ICAREdata Study portfolio
    • Extract and share ICAREdata outcome data from EHR using mCODE and FHIR

Target Outcome: 

  • Validate that ICAREdata EHR-based data are equivalent in accuracy to those achieved via the traditional clinical trial pathway
    • Support the collection of high-quality data in the EHR that is complete, accurate, and computable, in a way that enables clinical oncology research

    • Establishing a large scale, prospective collection and integration of high quality clinical data across multiple clinical care sites would increase the available data to include both data from clinical trials and high-quality EHR data

  • Establish an infrastructure with participating health systems that supports mCODE-enabled data collection, extraction, and sharing
  • Lay the groundwork for expanded exploration of the use of EHR data for clinical research


Project Plan

Phase

Milestone

Results

Timeline

DiscoveryUse case identification Focus on prospective collection of key outcome data in the EHR in a low-burden, structured way that can support clinical care and research

COMPLETE

Planning

Plan out high level project plan, deliverables, success measures, high level timeline, key stakeholders, etc


COMPLETE

Phase 1

Validate ability to prospectively collect high-quality data in the EHR

Successfully partnered with 2 clinical trials and 5 health systems to show agreement between EHR data collection and traditional clinical trials data collection when disease is absent: 96% concordance with 95% probability.

Motivated further study in ICAREdata Study Phase 2

COMPLETE

July 2019

Phase 2

Continue the expansion of mCODE adoption at health systems with ICAREdata use case.

Support the collection of high-quality EHR data, based on mCODE, to enable clinical oncology research. Expand on Phase 1 validation.

Onboarding ICAREdata health system and clinical trial partners to scale ICAREdata collection.

10 health systems with contracts. 7 health systems currently sharing data to the ICAREdata infrastructure.

Data analysis in progress.

ON TRACK

Dec 2023

Adverse Event ReportingTest an mCODE-compatible data model for adverse events that is embedded within the EHR. Focuses on usability, burden, and acceptance by providers, and secondarily considers comparison to similar items collected via traditional clinical trials data collection mechanisms.

Initial data model completed June 2021

Initial ICAREdata AE collection workflow documentation completed June 2021

Developed IT implementation tracker.

Extended project period into 2023. 

2 health systems currently sharing adverse events data to the ICAREdata infrastructure

ICAREdata AE project team agreed to leverage Vulcan clinical research AE implementation guide for ICAREdata AE project. There is much overlap with initial draft CTCAE IG. Vulcan CR AE IG will be balloted in Sept 2023 to become an HL7 FHIR standard.


ON TRACK

Oct 2023




Use Case Team

RoleNameOrganization
Scientific Leader, ICAREdataDr. Selina ChowAlliance for Clinical Trials in Oncology
Associate Director of the Data Lab,  ICAREdataNancy CampbellAlliance for Clinical Trials in Oncology
Project Manager, ICAREdataCassandra Elrahi (O'Connell)Alliance for Clinical Trials in Oncology
Project Coordinator, ICAREdata Project

Tatiana Armstrong


Alliance for Clinical Trials in Oncology
Use Case CoordinatorMaeve KokolusThe MITRE Corporation
Deputy Task LeadNicole LlewellynThe MITRE Corporation
Site Integration LeadMichelle CasagniThe MITRE Corporation
Technical LeadRob DingwellThe MITRE Corporation


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