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Activity Number: 513
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306184
Title: Predictive Power for Group Sequential Trials with Different Endpoint at Interim Look
Author(s): Shengyan Hong*+ and Songfeng Wang
Companies: MedImmune and University of South Carolina
Address: One Mediummune Way, Gaithersburg, MD, 20878, United States
Keywords: Predictive power ; group sequential trial ; interim futility analysis ; hazard ratio ; progression-free survival ; overall survival

In group sequential trials, the predictive power is a useful tool to estimate the probability of success at the final look based on observed data at an interim look. Oftentimes, the primary endpoint at the final look is a long term endpoint, such as overall survival in an oncology phase 3 trial, while the primary endpoint at an early interim look is a short term endpoint, such as progression-free survival, due to immaturity of the long term endpoint at the time of interim look. The predictive power described in the seminal book, Group Sequential Methods with Applications in Clinical Trials, by Jennison and Turnbull is not applicable to this situation because it is established for group sequential trials where the interim primary endpoint is same as the final primary endpoint. In this paper, we establish the predictive power for group sequential trials where they are different. An example is given to illustrate its use and its comparison to the predictive power established by Hong and Shi (Statistics in Medicine, 2012) to estimate the probability of success of a phase 3 trial based on observed data on a different endpoint from a separately conducted phase 2 trial.

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