Pooling WHODrug B3 Meeting Minutes September 2017

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2017-09-20

Agenda


Kick-off Slides: File:PhUSE WHODrug Pooling B3 Format SEP2017.pptx


Attendees


  • Deb Bauer
  • Greg Campbell
  • Amy Klopman
  • Jane Lozano
  • Joyce Leflar
  • Mercy Navarro
  • Diane Piper
  • Marlo Searcy
  • Siva Vobhilineni
  • Vera Voloshin
  • Lauren White


Not Present:

  • Susan Kenny
  • Shannon Labout
  • Changhong Shi
  • James Zuazo

Meeting Discussion


  • Marlo Searcy and Joyce Leflar presented an overview of the project description and deliverables



  • Attendees agreed that PhUSE Pooling WHODrug B3 Working group will need to collaborate closely with PhUSE Standard Scripts Analysis Working group, since the latter will propose the format for standard medication table summary in an upcoming white paper revision


  • Attendees agreed to meet on the 3rd Wednesday of each month at 10amPST/1pm EST moving forward. Schedule can be adjusted in future if needed. The December meeting will take place on the 13th to avoid holiday conflicts.


  • Jane Lozano provided additional information regarding the typical white paper review cycle process and timing. Draft white papers need to go through PhUSE review, public review, and informal FDA review before being finalized


  • Attendees agreed to target development of initial draft white paper for March 2018. This will coincide with the PhUSE US Computational Science Symposium. This symposium may provide a good opportunity for our working group to share current status and gather feedback on the initial draft if available. Final white paper draft will be targeted for June 2018, but this may require adjustment based on review process timing.


Action Items


  • Marlo will provide Lauren a list of meeting attendees, and Lauren will ensure that they have access to the PhUSE teamwork site


  • Marlo/Joyce will explore tools for document collaboration to support white paper development


  • Marlo will try to record future webex meetings if feasible


Upcoming Agenda Topics


  • Review Key Differences between WHODrug B2 and B3


  • Discuss possible high-level strategies for Data Pooling