A key question at the end of a company’s pivotal trial is, “Did we make our endpoints?” While demonstrating safety and effectiveness important, sponsors may be missing an even more important question. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk.
Developing key benefit-risk messages and communicating them effectively are critical in marketing applications, advisory panels and technology assessment committees. A thorough benefit-risk assessment is the foundation for the messages surrounding unmet need, proposed indication, patient population, clinical trial results and broader clinical application. Importantly, these data can provide the cost-benefit evaluation to make reimbursement decisions. The FDA framework considers factors such as the type, magnitude, duration, and probability of benefits; the nature of adverse events and device complications; disease characteristics; patient tolerance for risk; and the availability and benefit-risks of alternative therapies.
Using real-world examples, this presentation provides practice examples for each of the factors that contribute to a positive benefit-risk assessment. It will teach you how to communicate these assessments in marketing applications, and advisory panel presentations.
Learning Objectives: Upon the presentation’s conclusion, you should be able to:
- Identify the factors that comprise the benefit-risk assessment
- Develop key messages necessary to communicate a positive benefit-risk
- Tailor the benefit-risk messages to each key audience: FDA, advisory panel, payer, patient and health-care-practitioner
1:00pm - 2:00pm EST
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