Use of a Structured Framework for Evaluating Benefits and Risks of a Drug-Companion Diagnostic Combination
*Rebecca Noel, Eli Lilly and Company  *Margaret Warner, Eli Lilly and Company 


The use of a structured framework for benefit-risk assessment (B-RA) across the lifecycle of a drug is becoming standard practice for both the pharmaceutical industry and regulatory agencies. Frameworks facilitate decision making and improve transparency by including key decision factors such as context (condition to be treated, alternative therapies), key benefits and key risks, and the strengths and limitations of the evidence. To date, structured B-RA frameworks have been applied mainly to therapeutic products. This presentation will include examples of how a structured framework for the B-RA of a drug may be applied to a drug-companion diagnostic combination.