Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis

This webinar will be broadcast in Eastern Daylight Time (EDT)

Plan now on participating in this webinar series to learn more about current approaches to Benefit-Risk (B-R) assessment, including how to:

• Develop an understanding of the current B-R assessment initiatives and requirements
• Assess how scientific approaches applied in other fields may be employed as an aid to structured and transparent decision analysis in the field of medicinal products
• Discuss approaches and methods to enhance transparency and communication of B-R decisions
• Identify opportunities and challenges of implementing exploratory approaches to B-R assessment
• Identify and discuss processes and methods that may enhance B-R decision making, with the ability to:
• Engage multiple perspectives
• Quantify values
• Evaluate the impact of uncertainty
• Incorporate preference analysis and measurement
• Provide greater infrastructure and consistency
• Increase transparency

Assessing the Benefits and Risks of Medicines: Webinar Series Learning Objectives

• Describe the current status of B-R assessment and key initiatives
• Discuss approaches to perform B-R assessment to support and inform decision making
• Identify uses for B-R assessment, such as regulatory decision-making or communication with patients

Overview Part 7:

Regulatory authorities make difficult benefit-risk decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This session will discuss how outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.

Professionals involved in:

• Clinical Safety/Pharmacovigilance
• Risk Management/REMS
• Pharmacoepidemiology
• Regulatory Affairs
• Legal Affairs
• Medical Affairs
• Medical product safety assessment
• Marketing
• Clinical Research
• Medical Communications
• Statistics
• Comparative Effectiveness/HTAs/Health Outcomes
• Brand Commercial Teams

Additionally:

• Regulators facing complex benefit-risk (B-R) decisions, as well as regulatory and drug development policy makers
• Industry scientists involved in the evaluation of the B-R assessment of products in development or marketed products
• Patient representatives and advocates who wish to have greater representation of their needs and concerns in decision making
• Those wishing to learn more about the science and application of B-R assessment

Learning Objectives Part 7:

At the conclusion of this webinar, participants should be able to:

• Describe a health outcomes model that assesses drug safety and benefits
• Discuss how the application and use of quality adjusted life years (QALYs) is a framework for quantifying Benefit-Risk trade-offs for pharmaceuticals