2017-Aug-11 BiWeekly PhUSE Nonclinical ADA Endpoint Modeling

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<< Go back to the Investigating Endpoint Modeling - ADA Minutes Page When: 2017-08-11, 09:00-10:00 EDT
Place: Telecon



Participant Attended
Mike Wasko X
Gretchen Dean X
Thomas Bjerregaard X
Alan Brown
Christy Kubin
Janessa Pierce
Jennifer Emeneggee
Joleen White X
Joyce Ford
Kennan Marsh
Leslie Lorello X
Rihab Kordane X
Stephen MacMannis X
Trina Jiao
Wendy Freeburn X
William Houser X
Susan Steen X
Anna Pron-Zwick X
Dennis Stocker X
Jordan Li X


Next meeting: Aug 25, 2017 at 09:00 to 10:00 EDT

Meetings: 2 week schedule


Minutes Courtesy of Gretchen Dean

Given the discussion today I thought it might be nice to include an article with background on ADA testing. I think this Covance white paper is a nice summary. Testing is discussed on page 3: http://www.covance.com/content/dam/covance/assetLibrary/whitepapers/adawhitepaperpdf.pdf

I took down the following notes:

A summary of the interchange discussion was shared. Notes from this meeting can be found here: https://wiki.cdisc.org/display/TER/Anti-Drug-Antibodies+Modeling+Page Mike will also provide a PDF for those who cannot access. MRC= Modelling Review Committee

It was generally agreed that for now: the LB domain can be used with SENDIG 3.0 to model ADA data. Some companies may not have an IT solution in place that will allow them to model this data in IS domain (which was generally agreed to be the long term solution for this data). The other option mentioned was a custom domain could be considered.

Participants discussed various scenarios for ADA testing strategies and endpoints. We reviewed the IS example on the wiki. General agreement that “agent” would be sufficient to describe what the ADA method was specific toward and a nonstd variable is not needed (NSV).

Thomas will reach out to Craig Zwicki about using “function definition” (epitopes and cross reactivity). Not sure I captured this right

Action: All to review controlled terminology for “ISMETHOD”

Next meeting is 8/25. Mike will not be able to attend, but will have the go to meeting activated. Next meeting we will review some examples of data (Thomas and Leslie has previously volunteered).

Action Items

Responsible Task Timeframe
Mike Update Wiki Next few days
Group Each member to track down an example of data set used in submission for clinical (SDTM). Will likely need to reach out to clinical data management function within your organization (target 1 month) By next meeting
Group Future meeting – share example of anonymized/mock data (Leslie and Thomas – 8/11 & 25) Can be shared in excel format. By next meeting

Last revision by Mwasko79, 2017-08-16