RL32 Risk Model for Informing Protocol and Design
*Carolyn Carroll, Stat Tech Inc 


Current and future interventions, whether they are pharmaceuticals or devices are emerging in a more complicated framework than in the past. We are increasingly aware of the role of geonomics and protenomics in the effectiveness and safety of drugs. Engineering and materials advances have resulted in decreases in the size of new devices: nanoparticles and nanomaterials are one example. IF risk assessments are done early in design/development, safety and efficacy work can be more focused and as a result more informative. We will discuss potential model components and how these inputs can be used to inform protocols and design.