Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-01-12
<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page
When: 2016-01-12, 14:00-15:00 EST
Next meeting: Jan 14, 2016 at 11:30 to 12:30 EST
Meetings: 2 week schedule
-Asking who needs the discount to attend PhUSE CSS to get discount
-A common challenge in Standard for Exchange of Nonclinical Data (SEND) implementation is determining the appropriate method for incorporation of certain endpoints not modeled in the SEND Implementation Guide (SENDIG). Best practices for the inclusion of these data are needed to ensure consistent methodology. To address this need, the Investigating Endpoint Modeling PhUSE working group authored a white paper outlining best practices for the inclusion of endpoints such as biomarker, ADA and Immunophenotyping that are not modeled in the SENDIG. This poster presents the white paper concepts and conclusions.
-Authors: all names, for who came to calls. Two who are discounted first. Followed by alphabetically.
-Debra will submit abstract
-Christy will update flowchart.
-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|