Tutorial #3: Benefit-Risk Evaluation

Tutorial name:
Tutorial #3: Benefit-Risk Evaluation

Day & Time:
April 28, 1:30PM - 5:00PM

Registration Fees
- Standard Rate	$405.00

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.  

Event	Credit Type	Max Credits	CEU
Tutorial #3: Benefit-Risk Evaluation	ACPE IACET	3.25 3.25	0.325 0.300

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.