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
Eric Schaeffer, ThermoFisher Scientific
Working Group Publications & Resources:
<<Comprehensive Benefit-Risk Method Assessment (aBR)>>
A tool that includes real-world examples and applications of the method.
Publications Pending Completion:
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)
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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