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Problem and Target Outcome

Problem:

  • Clinical data is stored in disparate systems that use multiple data storage formats. Dispersed cancer treatment sites reporting to a centralized cancer registry presents many challenges for data aggregation.
  • Data collection and aggregation puts a high burden on both reporters and data registries. Reporting sites convey critical patient information using designated forms that require largely manual processes to complete, and each site has unique processes for clinical data collection.
  • Variability in patient data collection processes negatively impacts overall understanding of patient care. Heterogeneity of data collection makes it difficult to aggregate and share data for use in improving clinical research and standards of care.

Target Outcome:

  • Enable low-burden, standardized reporting of cancer data from cancer centers to registries that are aggregating data for different reasons.

  • Consider use of mCODETM and extensions for registry reporting to assess cross-center standards of care, starting with CAR-T therapy. Other potential scenarios could expand scope to support population health, clinical trials, post-market surveillance, quality reporting, comparative effectiveness and more.


Registry Reporting Details

ActorRegistries, Providers, Researchers, Patients
Description

A patient diagnosed with cancer is determined to need CAR-T. That patient begins therapy, and though a set of extended mCODE elements that patient’s status is tracked. As that patient’s therapy progresses, outcomes are tracked, and effectiveness of care is determined in real time. All this information is reported from the clinical site to the designated cancer registry, in a low-burden and semantically interoperable way. Connecting patient status, response, and disease progress provides greater insights into standards of care provided for CAR-T.

Trigger

Registries and reporting sites need an improved method for patient data reporting.

Preconditions
  • Demonstration of proof-of-concept collection of mCODE data for reporting purposes
  • Patient outcome before and after CAR-T is measurable
Postconditions

Reporting sites with CAR-T patients can seamlessly and easily transmit patient data to cancer registries with greater insights into standards of care around CAR-T patients, improving care understanding and practice.

Extensions

CAR-T includes a large number of data elements as a cellular therapy, and as an individualized option

Assumptions

Facilities have complete patient information/access to and ability to manage business of CAR-T

Scope

In Scope – Assessing standards of care for CAR-T using treatment mCODE element extensions, provided through a low-burden solution for registry reporting

Out of Scope – Prospectively assessing patient fit for CAR-T

Notes

Candidate elements include:

With a clinical focus –

  • Patient Status
  • Patient Reported Outcomes (PROs)
  • Adverse Events (CTCAE)

With an academic focus –

  • Academic medical centers already engaged in incorporating mCODE
  • Contract research



Conference Call Information

Important Dates

EventDate/Time






Use Case Team

RoleNameOrganizationEmail
Domain LeadGreg ShemancikThe MITRE Corporation

gshemancik@mitre.org











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