Pooling WHODrug B3 Meeting Minutes November 2017

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2017-11-15

Agenda


  • FDA Guidance Updates


  • Discuss additional pooling options (if any)


  • Determine pooling options to include in the draft white paper and any order of preference if applicable


  • Next steps to start drafting white paper, Collaboration Options


  • Time Permitting: Informal sharing around each company’s approach to WHODrug variable and ATC data model for SDTM submission

Attendees

  • Mary Bethala-Pinninti
  • Wendy Dobson
  • MaryAnn Huffert
  • Joyce Leflar
  • Laura Savard
  • Marlo Searcy
  • Changhong Shi
  • Lori VanMeter
  • Siva Vobhilineni
  • Vera Voloshin



Not Present:

  • Deb Bauer
  • Greg Campbell
  • Malin Jakobsson
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Jane Lozano
  • Mercy Navarro
  • Diane Piper
  • Lauren White
  • James Zuazo

Meeting Discussion




  • Marlo provided a summary of FDA Guidance Updates


  • Working group continued discussion of pooling options. No additional options were added by attendees.


  • Working group agreed to include all proposed options in white paper discussion. Preferred option may differ depending on whether legacy terminology is WHODrug B2 Format or a proprietary medication dictionary. Suggestion to rank options similar to MSSO MedDRA Upversioning levels - however, this may be difficult in WHODrug context, especially with different legacy terminologies.


  • For Option 3 (terminology Bridge), suggestion to broaden language to include bridge at any level (not just generic-generic)


  • Option 1 is Roche preferred approach when no specific medication analysis is included. Need to consider if this approach is feasible for most sponsors. Merck always includes a pooled concomitant medication table in the submission package.


  • Attendees agreed to pilot Google gDoc as document collaboration tool for working group white paper. Most attendees already have a Google profile/account. A Gmail account is not required to use gDocs. Marlo will provide account access and some basic instructions. gDoc invite may come from Marlo's personal email account (Genentech corporate email account limits gDoc sharing external to company).


  • After opening gDoc, please change from 'Editing' mode to 'Suggesting' mode in top right corner. This will allow changes to be tracked for group review.


Select drop-down for 'Editing' in top right corner:

Change Editing Mode Top Right Corner


GDoc1.5.png


Switch to 'Suggesting' in top right corner:

Select Suggesting Mode Top Right Corner


Action Items


  • Working group members to gather information about how WHODrug variables and ATC Classification information is/is planned to be modeled at their organization for SDTM compliant submission and be prepared to share at December meeting


  • Marlo will create initial White Paper Draft as starting place for working group collaboration using PhUSE template.


  • Marlo will create a Google gDoc to support working group document collaboration and provide group access.


  • Attendees will participate in white paper development by suggesting edits in the white paper gDoc.


Upcoming Agenda Topics


  • Informal sharing around each company’s approach to WHODrug variable and ATC data model for SDTM submission


  • Start discussing initial white paper draft