Pooling WHODrug B3 Meeting Minutes February 2018

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2018-02-21

Agenda


  • Start discussing initial white paper draft


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



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

  • Maryann Huffert
  • Joyce Leflar
  • Marlo Searcy
  • Changhong Shi
  • Nikolaos Sitaridis
  • Vera Voloshin



Not Present:

  • Deb Bauer
  • Mary Bethala-Pinninti
  • Greg Campbell
  • Wendy Dobson
  • Sybille Goetz
  • MaryAnn Huffert
  • Malin Jakobsson
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Jane Lozano
  • Mercy Navarro
  • Diane Piper
  • Laura Savard
  • Lori VanMeter
  • Siva Vobhilineni
  • Lauren White
  • James Zuazo

Meeting Discussion


  • Attendees reviewed suggested white paper changes in gDoc, and discussed approach to adjudicating specific comments


  • Attendees agreed to submit final suggestions to gDoc prior to March meeting.


  • Attendees shared SDTM modeling approach for WHODrug fields in CM domain:


  • Merck: Use SUPPQUAL for the additional ATC classes. When a drug has multiple ATC classes, all ATCs in SUPPQUAL are linked to a generic name in the parent domain. The CMCLAS and CMCLSCD variables in the parent domain will contain the word “MULTIPLE”. We will not manually select a single ATC class.


  • JNJ: Select primary class at ATC level 4 or most granular (CMCLASCD in CM dataset manually selected, so that single class displayed in parent CM domain). SUPPQUAL contains information about the additional ATC levels (level 3,2,1) for the selected primary ATC Class.


  • Otsuka: Manually select single primary class for parent CM domain at ATC level 4 or most granular. SUPPQUAL contains information about the additional ATC levels (level 3,2,1) for the selected primary ATC Class.


  • Genentech/Roche: Roche finds that the Findings About (FACM) domain is better suited than the Supplemental Qualifiers domain (SUPPCM) to display the many to one relationship between ATC class and generic, as well as the hierarchical definition of ATC Class. Plan on placing --CLAS in the Findings About domain (FACM) and populating with all associated ATC classes. The domain level relationship between CM and FACM can be defined within RELREC and allows for maximum analysis flexibility based on any ATC drug class, and at any hierarchical level if needed. Within FACM, a test code can be defined for each ATC classification level, and each coding path can be identified using FAGRPID, which will further support a machine readable approach.



Action Items


  • Attendees agreed to submit final suggestions to gDoc prior to March meeting.


Upcoming Agenda Topics


  • Finish discussing initial white paper draft and adjudicate any remaining changes


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