Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-08-27
<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-08-27, 14:00-15:00 EST
Next meeting: September 10, 2015 at 14:00 to 15:00 EST
Meetings: 2 week schedule
-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
-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||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|