Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-02-25
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When: 2016-02-25, 14:00-15:00 EST
Next meeting: Jan 14, 2016 at 11:30 to 12:30 EST
Meetings: 2 week schedule
-Abstract was accepted.
-Poster just about done. Went over last minor comments including those provided by Sue DeHaven.
-Decided on references for the poster. Sent to Christy for inclusion.
-Appears everyone is going to PhUSE
-Mike sent updated paper Christy made to match up with Poster. Everyone keep their own comments and then we can go through next meeting.
-Next meeting next week same usual time, Mike will send out an invitation.
-Discussed and attendees agreed current passage is acceptable.
-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"
|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|