Bayesian dose ‐finding phase I trial design incorporating historical data from a preceding trial
In this study, we propose to adaptively incorporate historical data into prior distributions assumed in a new dose‐finding trial. Our proposed approach aims to appropriately borrow strength from a previous trial to improve the maximum tolerated dose determination in another patient population. We define a “historical‐to‐current (H‐C)” parameter representing the degree of borrowing based on a retrospective analysis of previous trial data. In simulation studies, we examine the operating characteristics of the proposed method in comparison with 3 alternative approaches and assess how the H‐C parameter functions ...
Source: Pharmaceutical Statistics - January 26, 2018 Category: Statistics Authors: Kentaro Takeda, Satoshi Morita Tags: SPECIAL ISSUE PAPER Source Type: research
Bayesian dose ‐finding phase I trial design incorporating historical data from a preceding trial
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 25, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 25, 2018 Category: Statistics Source Type: research
Tobit regression for modeling mean survival time using data subject to multiple sources of censoring
Mean survival time is often of inherent interest in medical and epidemiologic studies. In the presence of censoring and when covariate effects are of interest, Cox regression is the strong default, but mostly due to convenience and familiarity. When survival times are uncensored, covariate effects can be estimated as differences in mean survival through linear regression. Tobit regression can validly be performed through maximum likelihood when the censoring times are fixed (ie, known for each subject, even in cases where the outcome is observed). However, Tobit regression is generally inapplicable when the response is sub...
Source: Pharmaceutical Statistics - January 23, 2018 Category: Statistics Authors: Qi Gong, Douglas E. Schaubel Tags: MAIN PAPER Source Type: research
Tobit regression for modeling mean survival time using data subject to multiple sources of censoring
Pharmaceutical Statistics,Volume 17, Issue 2, Page 117-125, March/April 2018. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 22, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 22, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics,Volume 17, Issue 1, Page 1-3, January/February 2018. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 21, 2018 Category: Statistics Source Type: research
Issue Information
Abstract
No abstract is available for this article. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 21, 2018 Category: Statistics Tags: ISSUE INFORMATION Source Type: research
Approaches to sample size calculation for clinical trials in rare diseases
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 10, 2018 Category: Statistics Source Type: research
Integrating dose estimation into a decision ‐making framework for model‐based drug development
Pharmaceutical Statistics,Volume 17, Issue 2, Page 155-168, March/April 2018. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 10, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 10, 2018 Category: Statistics Source Type: research
Approaches to sample size calculation for clinical trials in rare diseases
We discuss 3 alternative approaches to sample size calculation: traditional sample size calculation based on power to show a statistically significant effect, sample size calculation based on assurance, and sample size based on a decision‐theoretic approach. These approaches are compared head‐to‐head for clinical trial situations in rare diseases. Specifically, we consider 3 case studies of rare diseases (Lyell disease, adult‐onset Still disease, and cystic fibrosis) with the aim to plan the sample size for an upcoming clinical trial. We outline in detail the reasonable choice of parameters for these approaches for...
Source: Pharmaceutical Statistics - January 10, 2018 Category: Statistics Authors: Frank Miller, Sarah Zohar, Nigel Stallard, Jason Madan, Martin Posch, Siew Wan Hee, Michael Pearce, M årten Vågerö, Simon Day Tags: MAIN PAPER Source Type: research
Development of predictive signatures for treatment selection in precision medicine with survival outcomes
Pharmaceutical Statistics,Volume 17, Issue 2, Page 105-116, March/April 2018. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 3, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - January 3, 2018 Category: Statistics Source Type: research
