Recommendations for the Methodology and Visualization Techniques to Be Used in the Assessment of Benefit and Risk of Medicines: Findings from IMI Protect Consortium

• Activity Number: 350
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Gerald Downey*+ and Diana Hughes
• Companies: Amgen and Pfizer
• Keywords: Benefit-Risk ; Quantitative ; Qualitative ; Decision-Making ; Medicines ; Framework

Abstract

Under the umbrella of the IMI PROTECT consortium, members have advanced the understanding of both the integration and visual representation of benefit and risk data. Following a robust literature review, selected methodologies and visualisation techniques were applied in several case studies. The experieriences of the case study teams has been distilled into a clear set of practical recommendations organised around five stages of a generic benefit-risk assessment roadmap: (1) Planning (2) Evidence Gathering and Data Preparation (3) Analysis (4) Exploration (5) Conclusion and Dissemination While no single benefit-risk methodology can fully capture all aspects of a benefit-risk assessment, the choice of a single approach or combination of methodologies should be matched to the complexity of the problem. Several ongoing initiatives are examining the role of formal benefit-risk assessment methods, and PROTECT's experience makes a unique contribution which complements and builds on other efforts. The recommendations provided should serve as a valuable guide for readers new to the world of benefit-risk assessment as they highlight key issues/considerations that are common to many approaches.