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Date

October 9th, 2020 

Time

12:30pm - 1:15pm ET

Attendees

Action items

  •  Tarun Kumar/Salim Semy - send over IRB study protocol for Phase 1A when it is finalized. 
  • Salim - set up a call with UTSW and Elly. 
  • Caroline Potteiger - set up call with Seline.

Planned Agenda Topics

  • <Hold for hot topics from project team>
  • Past Action Items 10/02
  • Engagement Update
    • LUNGevity - met on October 8th, sent over more technical information 
    • TrialJectory - haven't heard back
    • Ciitizen - haven't heard back 
    • Epic - met internally to discuss optimized patient data elements and Rob sorted them into three buckets:
      • Can be accessed via Epic's FHIR services and mCODE extraction tool is built 
      • Data that is standardized and can be accessed, but extraction tool has not yet been developed
      • Data that is not standardized
    • Flatiron - don't have the bandwidth right now to work on this. 
    • TriNetX - ACS CAN will have a conversation with them next week. 
    • Stand Up 2 Cancer grant - ACS CAN is back in the running. 
  • Phase 1 Update
    • Working on IRB approvals for UTSW (Phase 1B) and MITRE/Cancer Insights (Phase 1A)
      • Phase 1A - team is reviewing documents. 
        • Salim is working on the informed consent document. 
        • 3 main artifacts - study protocol, agreements, privacy certifications. 
        • Sharon is drafting a 1-pager to share with patients and is planning to have it done on Tuesday. 
        • Next step is meeting with MITRE IRB to get a good sense of next steps. 
        • The plan: 
          • Enroll 10 patients into Cancer Insights and send their optimized patient data elements to matching services. Then, Sharon will do a more comprehensive match for clinical trials based on the whole record and compare the results.
          • We have the ability to add/pull patient data elements and can ask patients for missing information.
        • Once the IRB protocol is finalized, we should formulate a plan on exactly what we will do.
          • We should also get user input from the patients. 
      • Phase 1B - finalizing statistical section. 
        • Salim is working on simplifying the statistical analysis section. He will work with David and will then send it back to UTSW. 
        • Simplify statistical section. Salim will update it and run it by David and send it back to UTSW. Regroup next week. 
    • Massive Bio - curation of mCODE records is in progress. 
      • Done. 
      • Next - meet with Seline to discuss next steps. To keep comparisons within the same matching service, it would be ideal if Seline can search for clinical trials with just the optimized patient data. That way, the comparison with the full patient record is with the same matching service. 
    • UCSF - Elly has access to UCSF database, but she cannot share the data with anyone outside of UCSF without going through the CTSI consultation process.  
      • Undergo consultation process? 1 hour for free. 
      • Elly will start the process in getting this consultation set up. 
    • Implementation guide is complete - http://build.fhir.org/ig/standardhealth/fsh-pct/index.html
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