This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 469
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #307956
Title: Application of Methods for Assessing Risk-Benefit in Clinical Trials
Author(s): Menghui Chen*+ and Shailaja Suryawanshi
Companies: Merck & Co., Inc. and Merck & Co., Inc.
Address: 126 East Lincoln Avenue RY34-A304, Rahway, NJ, 07065,
Keywords: Bayesian ; Risk assessment ; Uncertainty ; Data interpretation ; Decision-making
Abstract:

Assessing risk-benefit across a clinical development program is a key decision-making factor both for regulators, consumers and the industry. Probabilistic methods such as the risk-benefit acceptability curve (RBAC) have been used for such an assessment. The distribution of therapeutic risk and benefit can be jointly modeled to understand incremental risks and benefits. An RBAC is then created by plotting the proportion of this joint density that lies below a range of values that reflect acceptability of the risk-benefit. These have also been considered in the Bayesian framework. Clear examples of these methods applied to clinical trial data and simulated data will be presented.


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