Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-06-04

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-06-04, 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 X
Troy Smyrnios
Audrey Walker
Steven Ward
Craig Zwickl X


Next meeting: June 18, 2015 at 14:00 to 15:00 EST

Meetings: 2 week schedule



We continued to work on the definition and list of biomarkers. Looked over the documents that Debra shared with group to support our current definition, and basing definition based off FDA guidance. Mike to update

Up to date, all the biomarkers provided by organizations appear to be clinical pathology measures.

Debra got email back from Jerry Salyers, CDISC Charter for biomarkers. , basically stating that whatever are biomarkers can be recorded in already existing domains. Is concurrent with our premise of the group. SDTM 3.2 basically covered all of this. Only difference is SEND does not have an IS domain as of yet.

Debra showed some documents from around web pertaining to biomarkers. Debra will share them with the group.

Craig pointed out with newer technologies or non-standard will require more information about methodology. Audrey pointed out how LBMETHOD is not required or contolled for SEND but is for SDTM and it is very useful and helpful for LB domain data and methodology.

Discussed multiple methods and possible outputs of the group. Discussed using current data model and SDRG as FDA is asking for more information from the report such as methods for biomarkers to be visible. This project looks to be evolving.

Currently only 5 organizations have submitted a top 20 Biomarkers, and are listed on the minutes page. Mike will change the format to be a table to track the number of incidence. Audrey confirmed one of the labs they use for Biomarkers put all biomarker results into the LB domain.

It appears that the speculation that the LB domain can handle all the biomarker data. Immunology makes things much more challenging. We plan to work possibly with the clinical team for LB. Audrey to get permission for many of us to join the Clinical Lab Team handling the new tests and units.

We hope to see everyone on June 4th at 14:00 EST. Please remember to inquire at your organizations about Biomarkers and forward them to Mike.

Next meeting look over definitions again.


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

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. By next meeting - continue

Last revision by Mwasko79, 2015-06-4