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Pharm Stat. 2018 Feb;17(1):61-73. doi: 10.1002/pst.1836. Epub 2017 Nov 10.

A dynamic power prior for borrowing historical data in noninferiority trials with binary endpoint.

Author information

1
Merck & Co., Inc., North Wales, PA, USA.

Abstract

Traditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group is often available from previous studies, it is interesting to consider a Bayesian approach in which information is "borrowed" for the control group to improve efficiency. However, construction of an appropriate informative prior can be challenging. In this paper, we consider a hybrid Bayesian approach for testing noninferiority hypotheses in studies with a binary endpoint. To account for heterogeneity between the historical information and the current trial for the control group, a dynamic P value-based power prior parameter is proposed to adjust the amount of information borrowed from the historical data. This approach extends the simple test-then-pool method to allow a continuous discounting power parameter. An adjusted α level is also proposed to better control the type I error. Simulations are conducted to investigate the performance of the proposed method and to make comparisons with other methods including test-then-pool and hierarchical modeling. The methods are illustrated with data from vaccine clinical trials.

KEYWORDS:

Bayesian; hierarchical model; noninferiority; power prior; test-then-pool

PMID:
29125220
DOI:
10.1002/pst.1836
[Indexed for MEDLINE]

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