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Date

November 13th, 2020

Time

12:30pm - 1:15pm 

Attendees

MITRE → Caroline PotteigerSalim Semy Rob DingwellLauren Levine 

ACS CAN → Mark Fleury

UTSW → Brandi Cantarel Melanie Hullings

BreastCancerTrials.org → Elly Cohen


Action items

  •  Lauren - set up meeting with Caroline, Salim, Zach, and Rob. 
  • Salim - draft a set of questions for the UCSF consult. 

Discussion notes in blue. Decisions in green. Action items in red.

Planned Agenda Topics

  • <Hold for hot topics from project team>
    • HL7 Biomedical Research and Regulation Group agreed to sponsor this project! 
  • Past Action Items 11/06
  • CoP next week - need to reschedule. 
  • Engagement Update
    • TrialJectory - meeting scheduled for 11/12. 
    • Ciitizen - met with them on 11/12
      • 1) Test how well the optimized patient data elements filter clinical trials. Run a match with only optimized patient data elements and compare with comprehensive patient record match. 
      • 2) mCODE-enable the matching service and cancer card. 
    • TriNetX - internal discussions
    • Inspirata - continuing discussions. 
      • Could work with UCSF dataset. Inspirata has an NLP engine that could work with unstructured data.  
    • Informa - acquired TrialScope. Conversation scheduled for next week. 
      • Mark spoke with them a few weeks ago. They have a private trial database. Can understand what trials the competition is running. Previously mentioned they were not interested in searching for clinical trials. 
    • Meeting next week for site engagement. 
    • RXL CRO showed interest. Mark following up. 
  • Phase 1 Update
    • Working on IRB approvals for UTSW (Phase 1B) and MITRE/Cancer Insights (Phase 1A)
      • Phase 1A -
        • MITRE IRB has been re-submitted and DUA has been approved. 
      • Phase 1B - 
        • Melanie is working on the submissions. 
        • MITRE is working on the DUA. 
    • Massive Bio - in progress. 
      • Getting initial results, but they need some work. 
      • Lauren - set up meeting with Caroline, Zach, Rob, 
    • UCSF - consult is occurring next week.  
      • What mechanisms exist for us to access the data under CodeX with multiple organizations? Other CodeX use cases? Prefer to not to create individual DUAs. 
      • Salim - draft a set of questions to ask (legal, what data exists). 
  • Phase 1 Analysis 
    • ACS CAN intern
      • Fellow was hired - starts on Monday
        • For any DUAs being signed, she would need to see the data. 
          • Trying to figure out how to structure DUAs so it's not just between organizations, but under CodeX as a whole so everyone on the team can view the data. 
        • Help write protocols, review data, analyze data, etc. 
    • Plan for analysis?
      • Potential elements to add - measurable disease (bone metastasis is not eligible), line of therapy 
      • Potential elements to remove - elements that may not be readily available (histology, biomarkers) 
      • If something is not present, how do we know it's because it's absent or it just wasn't recorded?
        • Caroline meeting with spec team next week. 
    • Salim/Caroline met with statistician on 11/12.
    • Our analysis on how many "true matches" there are is going to depend on how many total matches come back 
      • 1 match in 5 = good filtering, 20 matches in 100 = bad filtering 
    • Patient data elements we add must be populated by both clinical trials and what's available from the patient record.
    • False negatives are ones we really want to eliminate and make sure they don't happen. 


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