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Activity Number: 162 - Statistical Challenge and Issues in Vaccine Development
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #329599 Presentation
Title: Application of Futility Testing in Vaccine Outcome Studies (With a Recent Example)
Author(s): Aiying Chen* and Scott Patterson and Ehab Bassily
Companies: Sanofi Pasteur and Sanofi Pasteur and Sanofi Pasteur
Keywords: vaccine studies ; stopping for futility ; stopping rules

Futility testing are often designed into phase II/III clinical trials to test the treatment effects over short period to see if the treatment is likely to beat the control and worthy further study. Early stopping for futility during interim analysis become increasing popular for later phase pivotal outcome clinical trials to save time, money, patient unnecessarily exposure and other resources that could be used in other promising research. The available methods for futility stopping are mostly based on conditional power or predictive power in conjunction with the theory of stochastic curtailment or group sequential design. We consider the application of these methods to a recent outcome study design (data are disguised to actual vaccine and endpoint), and show that these methods are readily applicable to vaccine studies.

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

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