Pooling WHODrug B3 Meeting Minutes January 2018

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2018-01-17

Agenda


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


  • Start discussing initial white paper draft


  • Plan for CSS Meeting: Are we ready to share WP draft? Can anyone attend?


White Paper Draft gDoc Instructions



White Paper Draft gDoc Link: https://docs.google.com/document/d/131XoHMd4ykSGvKzMGd8Xbarkfop58ovbSr5w7m9wi0k/edit?usp=sharing



1. 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.

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

Change Editing Mode Top Right Corner


GDoc1.5.png


3. Switch to 'Suggesting' in top right corner:

Select Suggesting Mode Top Right Corner


4. Specify your name/initials in comment fields (otherwise, comments will be marked as Anonymous if not signed into a google account).


Attendees

  • Greg Campbell
  • Wendy Dobson
  • MaryAnn Huffert
  • Malin Jakobsson
  • Joyce Leflar
  • Veena for Diane Piper
  • Marlo Searcy
  • Siva Vobhilineni
  • Vera Voloshin



Not Present:

  • Deb Bauer
  • Mary Bethala-Pinninti
  • Sybille Goetz
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Jane Lozano
  • Mercy Navarro
  • Laura Savard
  • Changhong Shi
  • Lori VanMeter
  • Lauren White
  • James Zuazo

Meeting Discussion

  • No attendees had had a chance to review or provide comments on the white paper draft prior to the meeting. Agreement that attendees will make an effort to do this prior to the next meeting in February.


  • Since initial white paper discussion will be postponed until February, attendees agreed that it would be premature to discuss this at the CSS Meeting (March 4-6, Maryland).


  • Marlo reviewed gDoc access information and provided high-level overview of white paper draft sections.


  • Group discussed current FDA guidance on WHODrug and differences in sponsor interpretation.


  • Marlo shared Roche/Genentech planned approach to modeling WHODrug B3 Format with ATC Class information for SDTM submission. Roche currently plans to use the Findings About (FACM) domain for ATC Class information (difficult to model all related ATC variables in SUPPCM). See Meeting Slides. Roche Clinical/Safety stakeholders want all ATC classes, and all ATC levels available for internal reporting and exploratory analysis. Roche does not support or see analysis value in ATC Class selection based on intended use. Roche will be providing public comment on this topic related to Technical Conformance Guide revisions.


  • Greg shared Gilead's proposed modeling approach. SDTM CMCLAS will contain single ATC or 'MULTIPLE' per UMC guidance. SUPPCM domain will contain information about all ATC Classes (with modification to QNAM and other variable naming conventions). Gilead currently uses the DDA Exclusive table for ATC Class information. Project teams can derive ATC Level 4 or ATC Levels 2 +4, depending on analysis need. Adding this information to SUPPCM can make the table very large.




Action Items


  • Working Group participants review white paper draft and be prepared to discuss and comment by next meeting on February 21st.


Upcoming Agenda Topics


  • Start discussing initial white paper draft


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