November 13th, 2020
12:30pm - 1:15pm
MITRE → Caroline PotteigerSalim Semy Rob DingwellLauren Levine
ACS CAN → Mark Fleury
UTSW → Brandi Cantarel Melanie Hullings
BreastCancerTrials.org → Elly Cohen
- 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.