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Problem and Target Outcome

Problem:

  • Most cancer patients who enroll in clinical trials learn of these opportunities from their providers or from study staff, but most hospitals do not run trials.
  • Existing patient-facing tools for clinical trial matching typically require a challenging amount of manual clinical data entry and / or manual review of trials.

Target Outcome:

  • Develop open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching services
    • Drive awareness of and commitment to use these standards in the industry
    • Thereby improve clinical trial matching for patients and their care teams


EPFCT Details

ActorCancer patient. 
Description

A cancer patient identifies clinical trials for which she may be eligible. She uses tools that she can access directly, and she does not have to do manual transcription of clinical data. Rather, the patient facing matching tools leverage structured patient data from the electronic health record (EHR) and structured descriptions of clinical trial eligibility criteria to assess matches.

Trigger

Patient wants to identify clinical trials for which she meets the eligibility criteria to enroll.

Preconditions
  • Required patient data exists in a structured computable format
  • Patient has access to use clinical trial matching tool
Postconditions

Patient views a list of clinical trials in which she may be eligible to enroll.

Extensions

What if there are no matching clinical trials?

Assumptions

What do we accept to be true? May need to be validated by partners.

ScopeThis use case addresses patients finding clinical trials. Providers use of the clinical trial matching tool on behalf of their patients is covered in a separate use case. 
Notes

ACS CAN is involved in a workgroup that is analyzing which data elements are most impactful for capturing trial eligibility criteria. Candidate elements include:

  • Diagnosis (primary)
  • Diagnosis (secondary subtype/histology)
  • Tumor Stage
  • Metastatic status and location
  • Biomarkers (options may vary by cancer type)
  • Performance status
  • Prior/concurrent malignancy
  • Immune function /viral infection status (Hepatitis, HIV)



Conference Call Information

Important Dates

EventDate/Time






Use Case Team

RoleNameOrganizationEmail
Domain LeadAmmu IrivintiThe MITRE Corporation

sirivinti@mitre.org 

Domain LeadSalim SemyThe MITRE Corporation

ssemy@mitre.org 







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