Benefit-Risk Evaluation (aBR)

Assessment of Benefit-Risk Evaluation (aBR) Working Group

This team is evaluating an aggregated risk/benefit tool across multiple use cases to provide a method for evaluating multiple risks and benefits simultaneously. These examples will demonstrate to CTQ members what this method looks like for their products, leading to adoption decisions.

Working Group Leader:

Contributors:

Shannon Hoste, Pathway for Patient Health - Project Manager

Chris Hoag, Stryker

Mandar Karhade, Citingale

Clarence Murray III, STERIS

David Onuskanich, Gilead

Xavier-Lewis Palmer, PhD, BIOSVIEW

Eric Schaeffer, ThermoFisher Scientific

Working Group Publications & Resources:

Publications Pending Completion:

1. Assessing the Objectivity of Evaluating Risk Inputs to the Benefit-Risk Method

   Fatemeh Jahed, PhD Candidate at the 

   Else Kröner Fresenius Center for Digital Health (Germany)

2. Draft Standard: Simplify the Benefit-Risk Equation via Excel VBA Program

   Xavier Plymer, Lead Author

   Mandar Karhade, Contributor

Check Back for more publications that will be announced soon!

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