Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-01-07

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2016-01-07, 14:00-15:00 EST
Place: Telecon



Participant Attended
Mike Wasko X
Debra Oetzman X
Brian Argo
Kathy Brown X
Donna Danduone
Jennifer Feldmann
Karolyn Forlenzo
Pierre Jambaud
George Kahlbaugh
Christy Kubin X
Catherine Roy X
Audrey Walker
Steven Ward
Craig Zwickl


Next meeting: Jan 12, 2016 at 14:00 to 15:00 EST

Meetings: 2 week schedule



-Discussed the abstract for PhUSE CSS

-New members of the group introduced, Brian Argo and Christy Kubin from MPI Research

-Deadline for Abstract is January 15th with 100 - 150 words.

-Christy Kubin has volunteered to give the abstract a shot and will send out a draft early next week to the group.

-Group asked to review the abstract along with the most current draft of the paper with the exception of the diagram.

-Paper has significantly changed since the diagram was initially created.

-Needs a full rework of diagram if group feels paper still needs diagram with new content of paper. Have it fresh in our heads.

-Discussed that at PhUSE should discuss with FDA if they would like a biomarker flag or is it irrelevant



Identified Need/Challenge
-Discussed and attendees agreed current passage is acceptable.

Project Scope'
-While there are many additional endpoints, such as pharmacodynamics, T-Dar, etc., we begin our investigation and exploration in Biomarkers, ADA (Anti-Drug Antibodies), and Immunophenotyping. The group will also research what the clinical side has done with regard to these endpoints to ensure alignment where possible.

-Formulate a broad definition of what biomarkers are, and provide guideline when custom domains are needed or when exisiting domains can or should be used. -Some definitions discussed. See the Charter for CDISC SDS Biomarker Subteam and will be used as the definition.

-To suggest methods to facilitate endpoint modeling using existing domains as opposed creating new or custom domains. Answer the question of "What is the process for identifying whether a data endpoint should go into an existing domain or a custom domain"


Action Items

Last revision by Mwasko79, 2016-01-7

Responsible Task Timeframe
Mike Ask George for copy of the Visio image - visio file Completed
Mike Distribute draft to team for extra review Completed
Craig Take a shot at a second draft Completed
Mike Update Wiki Next few days
Debra Distribute Biomarker literature to group Completed
Debra Provide Phuse Leadership with the update from our working group Debra provided
Group Take question back to prospective organizations what a Biomarker is Completed
Debra Email Jerry Salyers about CDISC Biomarker team and their findings Completed, received email back from Jerry
Mike Upload the Scanned sheets of the group intent from Phuse CSS Meeting also CDISC definition of Biomarker Next few days - Completed.
Group Approach organizations to ask top 10 or 20 endpoints and a few odd balls in the biomarker arena and email to group Almost Complete
Mike Tabulate top 10 or 20 biomarkers from group By next meeting - continue
Audrey Get permission for many people from team to join Clinical Lab Team Next meeting
Mike Add Biomarker definition from FDA page. Completed
Debra Look into SDTM to see what other grouping qualifiers available Completed