Tutorial name:Tutorial #3: Benefit-Risk Evaluation
Day & Time:April 28, 1:30PM - 5:00PM
Instructor(s):Scott Evans, PhD
Senior Research Scientist
Harvard University School of Public Health, United States
John H. Powers, MD,FACP
Associate Clinical Professor of Medicine
George Washington University School of Medicine, United States
Description:The monitoring and evaluation of benefit-risk is a fundamental element of clinical trials and development programs. Despite benefit-risk evaluation lying at the heart of this research, there is a need for improved evaluation through critical thought and more structured evaluation. We discuss the challenges to benefit-:risk assessment, review methods that have been proposed for benefit-risk evaluation, and present ideas for improved design, monitoring, analyses, and reporting of benefits and risks. Methods for incorporating patient preferences and weighting outcomes, and novel ideas for tailored/personalized medicine using within-patient analyses of benefits and risks will be presented.
Learning Objective(s):At the conclusion of this tutorial, participants will:
- Recognize the challenges of benefit/risk evaluation
- Discuss approaches to benefit-risk evaluation that can be used as a foundation for building new approaches for improved design, monitoring, analyses, and reporting
Target Audience:Statisticians, clinicians, and others working in clinical trials and development programs with interest in benefit-risk evaluation.