Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-08-27

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-08-27, 14:00-15:00 EST
Place: Telecon

Logistics

Attendance

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


Meetings

Next meeting: September 10, 2015 at 14:00 to 15:00 EST

Meetings: 2 week schedule

Minutes

General

-Mike shared a Biomarker webinar which he will share with the group

-Debra shared a TAU for Asthma standard from CDISC with examples that shows no flagging of biomarkers from clinical http://www.cdisc.org/system/files/all/standard_category/application/pdf/taug_asthma_20v1.0_20noportfolio.pdf

-Discussion is if we are different in how we use biomarkers than clinical.

-Craig will ask FDA at face to face, if there needs to be differentiation for biomarker

-Decided to go ahead with paper, as it seems to be relevant and may also help with future gaps

-Started to draft outline for the white paper which Mike will email to team

-George volunteered to do the introduction draft

-Debra volunteered to do Recommendation section draft

-Mike volunteered to do Investigation Phase draft

-By next meeting have a somewhat working draft

-Want to get feedback from PhUSE higher level groups on paper when have a final draft

Wiki

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.

Vision
-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"

Milestones'


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