Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-08-13

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-08-13, 14:00-15:00 EST
Place: Telecon



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


Next meeting: August 27, 2015 at 14:00 to 15:00 EST

Meetings: 2 week schedule



-. Everyone has provided data. Would everyone like the sheet to include company provided by? -Mike will tabulate list for next meeting.

-Craig suggested maybe ask FDA at CDISC if we need to make a distinction of biomarker.

-May need dual purpose samples/categories since may multipurpose sample for multiple tests.

-As a group, we just need a consideration section for people to refer to decide how they would like to report biomarkers in SEND. Based on transmission not use purposes.

-Goals may change as CDISC comes out with new domains and practices in clinical.

-Discussed do you need EX for articles administered to create a state\study design such as KLH or sham dosing etc

-Biomarkers really aren't a scientific class, but more of a handling/analytical/usage class.

-Best method probably to use a category to differentiate such a flag, or LBSCAT or even LBTPT (4h Biomarker)

-Biomarkers could even really be in PC and PP for Biologics if they are the metabolite

-Next meeting will come up with outline for the paper.


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, 2015-08-27

Responsible Task Timeframe
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