Graphical Presentation of Benefit-Risk Profile

• Activity Number: 324
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Weili He* and Shihua Wen and Scott R. Evans
• Companies: Merck and AbbVie and Harvard University
• Keywords: Benefit-risk ; QSPI ; Graphical display

Abstract

The purpose of graphics or visualization tools for benefit-risk assessment and presentation (BRAP) of medicinal products is to illuminate effects and aid decision-making among different stakeholders including the patients, clinicians, sponsors, regulatory agencies, and payers. Thoughtful and creative utilization of graphical displays in benefit-risk assessment can help to deliver safe and effective interventions to the patients and can enhance the development process. In this talk, we present a thorough review of graphical presentations by the QSPI Benefit-risk Working Group that have appeared in the medical and statistical literature, including peer-review journals, special interest group publications, scientific reports, and FDA advisory committee meeting materials, is presented. Based on the review and with a focus on application to the clinical trial setting, new perspectives and guidance for the application of graphics is presented. Refinements to existing graphics are provided, along with illustrative case studies providing readers with appropriate context for appropriate use of various graphics in practice.