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Full-Text Articles in Biostatistics

Shrinkage Priors For Isotonic Probability Vectors And Binary Data Modeling, Philip S. Boonstra, Daniel R. Owen, Jian Kang Jan 2020

Shrinkage Priors For Isotonic Probability Vectors And Binary Data Modeling, Philip S. Boonstra, Daniel R. Owen, Jian Kang

The University of Michigan Department of Biostatistics Working Paper Series

This paper outlines a new class of shrinkage priors for Bayesian isotonic regression modeling a binary outcome against a predictor, where the probability of the outcome is assumed to be monotonically non-decreasing with the predictor. The predictor is categorized into a large number of groups, and the set of differences between outcome probabilities in consecutive categories is equipped with a multivariate prior having support over the set of simplexes. The Dirichlet distribution, which can be derived from a normalized cumulative sum of gamma-distributed random variables, is a natural choice of prior, but using mathematical and simulation-based arguments, we show that …


A Modular Framework For Early-Phase Seamless Oncology Trials, Philip S. Boonstra, Thomas M. Braun, Elizabeth C. Chase Jan 2020

A Modular Framework For Early-Phase Seamless Oncology Trials, Philip S. Boonstra, Thomas M. Braun, Elizabeth C. Chase

The University of Michigan Department of Biostatistics Working Paper Series

Background: As our understanding of the etiology and mechanisms of cancer becomes more sophisticated and the number of therapeutic options increases, phase I oncology trials today have multiple primary objectives. Many such designs are now 'seamless', meaning that the trial estimates both the maximum tolerated dose and the efficacy at this dose level. Sponsors often proceed with further study only with this additional efficacy evidence. However, with this increasing complexity in trial design, it becomes challenging to articulate fundamental operating characteristics of these trials, such as (i) what is the probability that the design will identify an acceptable, i.e. safe …