Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power, assurance and related concepts. This book brings together recent research and sets them in a consistent framework and provides a fresh insight into how such methods can be used. Features: A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. Extensions of the concepts to binomial, and time-to-event outcomes and non-inferiority trials An investigation into the upper bound on average power, assurance and Bayesian power based on the prior probability of a positive treatment effect Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program, or to the successful outcome of an interim analysis Prior distribution of power and sample size Extension of the basic approach to proof-of-concept trials with dual success criteria Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect, and an unconditional version.
When in 1981 Louis and Walter Alvarez, the father and son team, unearthed a tell-tale Iridium-rich sedimentary horizon at the 65 million years-old Cretaceous-Tertiary boundary at Gubbio, Italy, their find heralded a paradigm shift in the study of terrestrial evolution. Since the 1980s the discovery and study of asteroid impact ejecta in the oldest well-preserved terrains of Western Australia and South Africa, by Don Lowe, Gary Byerly, Bruce Simonson, Scott Hassler, the author and others, and the documentation of new exposed and buried impact structures in several continents, have led to a resurgence of the idea of the catastrophism theory of Cuvier, previously largely supplanted by the uniformitarian theory of Hutton and Lyell. Several mass extinction of species events are known to have occurred in temporal proximity to large asteroid impacts, global volcanic eruptions and continental splitting. Likely links are observed between asteroid clusters and the 580 Ma acritarch radiation, end-Devonian extinction, end-Triassic extinction and end-Jurassic extinction. New discoveries of ~3.5 – 3.2 Ga-old impact fallout units in South Africa have led Don Lowe and Gary Byerly to propose a protracted prolongation of the Late Heavy Bombardment (~3.95-3.85 Ga) in the Earth-Moon system. Given the difficulty in identifying asteroid impact ejecta units and buried impact structures, it is likely new discoveries of impact signatures are in store, which would further profoundly alter models of terrestrial evolution. .
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