Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-06-18
<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-06-18, 14:00-15:00 EST
Next meeting: June 18, 2015 at 14:00 to 15:00 EST
Meetings: 2 week schedule
-Kathy Brown and Pierre will send Mike their list of Biomarkers. -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.
-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.||By next meeting - continue|
|Mike||Take poll about attendence for meeting on July 2nd, and cancel if needed||next few days|