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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 – less than 6% 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

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 clinical site partners have begun to implement the ICAREdata collection and extraction tools.
  • Data collection of ICAREdata data elements (either in partner trials and/or standard of care patients) is underway at 4 clinical sites.
  • 5 clinical trials have ICAREdata language embedded in their protocols.
  • Clinical trial partnerships are also growing with the introduction of a companion study protocol enabling collaboration with ongoing trials. 

ON TRACK

Sept 2021

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

ON TRACK

Fall 2022




Use Case Team

RoleNameOrganization
Senior Director, ICAREdataKeri SafaiiAlliance for Clinical Trials in Oncology
Project Manager, ICAREdataCassandra Elrahi (O'Connell)Alliance for Clinical Trials in Oncology
Clinical Research Nurse Manager, ICAREdataNancy CampbellAlliance for Clinical Trials in Oncology
Use Case CoordinatorMiranda ChanThe MITRE Corporation
Health Systems Engagement LeadTina CrottyThe MITRE Corporation
Site Integration LeadMichelle CasagniThe MITRE Corporation
Technical LeadRob DingwellThe MITRE Corporation


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