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