Abstract:
:In literature, there are a few unified approaches to test proof of concept and estimate a target dose, including the multiple comparison procedure using modeling approach, and the permutation approach proposed by Klingenberg. We discuss and compare the operating characteristics of these unified approaches and further develop an alternative approach in a Bayesian framework based on the posterior distribution of a penalized log-likelihood ratio test statistic. Our Bayesian approach is much more flexible to handle linear or nonlinear dose-response relationships and is more efficient than the permutation approach. The operating characteristics of our Bayesian approach are comparable to and sometimes better than both approaches in a wide range of dose-response relationships. It yields credible intervals as well as predictive distribution for the response rate at a specific dose level for the target dose estimation. Our Bayesian approach can be easily extended to continuous, categorical, and time-to-event responses. We illustrate the performance of our proposed method with extensive simulations and Phase II clinical trial data examples.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Tang Y,Cai C,Sun L,He Jdoi
10.1080/10543406.2017.1293081subject
Has Abstractpub_date
2017-01-01 00:00:00pages
975-989issue
6eissn
1054-3406issn
1520-5711journal_volume
27pub_type
杂志文章abstract::The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highl...
journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543400903242753
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章,评审
doi:10.1080/10543406.2014.972511
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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