Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-07-30
<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-07-30, 14:00-15:00 EST
Next meeting: July 30, 2015 at 14:00 to 15:00 EST
Meetings: 2 week schedule
-. Everyone has provided data. Would everyone like the sheet to include company provided by? -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.
-Audrey suggested adding a SUBCAT of Biomarkers. Current CRL practice. Also use for other distinctions such as Excretions, Morphology,
-Mike passed on the findings from CDISC GeneTox group. Group agrees our focus still as does not really affect us.
-Audrey noted that if information is included in the report and/or protocol, it does not need to be included in SDRG as per Tim Kropp.
- Craig noted the fact that Biomarkers are really a filter and analytical tool, and do not really dictate what domains the data should go into.
-Biomarkers really aren't a scientific class, but more of a handling/analytical/usage class.
-Biomarkers could even really be in PC and PP for Biologics if they are the metabolite
-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|
|Mike||Take poll about attendence for meeting on July 2nd, and cancel if needed||next few days|