Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-07-30

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-07-30, 14:00-15:00 EST
Place: Telecon



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


Next meeting: July 30, 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 trying to find a way to manage SEND terms separate from Clinical. Perhaps separate codelists for preclinical vs clinical due to length.

-Mike said maybe a biomarker flag on LB or on SDRG.

-Audrey suggested adding a SUBCAT of Biomarkers. Current CRL practice. Also use for other distinctions such as Excretions, Morphology,

-Mike passed on the findings from CDISC GeneTox group. Group agrees our focus still as does not really affect us.

-Audrey noted that if information is included in the report and/or protocol, it does not need to be included in SDRG as per Tim Kropp.

- Craig noted the fact that Biomarkers are really a filter and analytical tool, and do not really dictate what domains the data should go into.

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

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


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, 2015-07-30

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
Mike Take poll about attendence for meeting on July 2nd, and cancel if needed next few days