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Abstract Details

Activity Number: 660
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305736
Title: Decision Rule Based on a Noninferiority Trial
Author(s): Madhuja Mallick*+
Companies: Forest Laboratories Inc
Address: , , , United States

In clinical trials, a placebo-controlled trial is common to demonstrate medical efficacy and safety/tolerability of the treatment of interest. However to demonstrate the treatment of interest is not worse than the already marketed treatment in the disease area, a non-inferiority trial can be appropriate. Non-inferiority trials often suffer from some challenges in their design. This presentation will discuss some challenges in carrying out a non-inferiority trial with clinical trial examples. It is also of interest to quantitatively estimate the probability of success. There are various means of accomplishing this: simple frequentist methods, Bayesian approaches. Bayesian methods would weight prior information and beliefs alongside data generated from the earlier trials in a model-based approach. Examples of such procedures will be demonstrated via simulation using a clinical trial example.

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