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Activity Number: 372
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #315574
Title: A Case Study on Practical Patient-Level Benefit-Risk Assessment in a Clinical Trial
Author(s): Bo Fu* and Shihua Wen
Companies: AbbVie and AbbVie
Keywords: Benefit-risk assessment ; Clinical trial ; Patient-level

Various qualitative or quantitative Benefit-Risk (B-R) assessment methods have been developed over the past decade, majority of them focus on the population or study level though. However, as patients with the same disease may have different level of physical quality and tolerance for the treatment, benefit-risk decision determined at the patient level may be more meaningful to the individual patient. In this case study, a number of patient-level benefit-risk assessment methods including graphical methods have been applied to a single-arm study in oncology area. In addition, a comparison between patient-level and study-level benefit-risk assessment will also be discussed.

Authors who are presenting talks have a * after their name.

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