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Clinical Trial Methodology
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods …
Statistical Design and Analysis of Stability Studies
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing …
Multiple Testing Problems in Pharmaceutical Statistics
Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians …
Biostatistics: A Computing Approach
The emergence of high-speed computing has facilitated the development of many exciting statistical and mathematical methods in the last 25 years, broadening the landscape of …
Bayesian Methods for Measures of Agreement
Using WinBUGS to implement Bayesian inferences of estimation and testing hypotheses, Bayesian Methods for Measures of Agreement presents useful methods for the design and analysis …
Dose Finding by the Continual Reassessment Method
As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two …
Randomized Clinical Trials of Nonpharmacological Treatments
Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, …
Frailty Models in Survival Analysis
The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved …
Joint Models for Longitudinal and Time-to-Event Data
In longitudinal studies it is often of interest to investigate how a marker that is repeatedly measured in time is associated with a time to an event of interest, e.g., prostate …
Elementary Bayesian Biostatistics
Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern …
Design and Analysis of Clinical Trials with Time-to-Event Endpoints
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or …
Design and Analysis of Bioavailability and Bioequivalence Studies
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of …