What if the life you built disappeared overnight-and you had to create a new one from the ground up?In 2004, Dr. Simon Kirby was living the life he had worked decades to achieve. A successful facial plastic surgeon, husband, father, and lifelong high achiever, he appeared to be at the peak of his profession. Then a catastrophic vertebral artery dissection triggered a brainstem stroke that stopped his heart, left him in a coma, and stripped away nearly everything he...

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first editi...

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate...

In the past thirty years epidemiology has matured from a fledgling scientific field into a vibrant discipline that brings together the biological and social sciences, and in doing so draws upon disciplines ranging from statistics and survey sampling to the philosophy of science. These areas of knowledge have converged into a modern theory of epidemiology that has been slow to penetrate into textbooks, particularly at the introductory level. Epidemiology: An Introduction closes the...

Praise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehens...

Now in a fully revised Fourth Edition, Modern Epidemiology remains the gold standard text in this complex and evolving field. This edition continues to provide comprehensive coverage of the principles and methods for the design, analysis, and interpretation of epidemiologic research. Featuring a new format allowing space for margin notes, this edition • Reflects both the conceptual development of this evolving science and the increasing role that epidemiology plays in improving public heal...

Meta-analysis decision analysis and cost-effectiveness analysis are the cornerstones of evidence-based medicine. These related quantitative methods have become essential tools in the formulation of clinical and public policy based on the synthesis of evidence. All three methods are taught with increasing frequency in medical schools and schools of public health and in health policy courses at the undergraduate and graduate level. This book is a lucid introduction and will serve the needs o...

One of the most crucial skills a clinician, scientist, or student can learn is to create, conduct, and interpret the conclusions of a clinical study. Critical Thinking in Clinical Research teaches these fundamentals in four distinct sections, called “units”: the first unit focuses on issues surrounding the design of a study such as population, question selection, randomization, and blinding; Unit 2 presents statistical methods such as analyzing data collected, how to present and d...

This volume, representing a compilation of authoritative reviews on a multitude of uses of statistics in epidemiology and medical statistics written by internationally renowned experts, is addressed to statisticians working in biomedical and epidemiological fields who use statistical and quantitative methods in their work. While the use of statistics in these fields has a long and rich history, explosive growth of science in general and clinical and epidemiological sciences in particular h...

A new edition of the classic guide to the use of statistics in medicine, featuring examples from articles in the New England Journal of MedicineMedical Uses of Statistics has served as one of the most influential works on the subject for physicians, physicians-in-training, and a myriad of healthcare experts who need a clear idea of the proper application of statistical techniques in clinical studies as well as the implications of their interpretat...

This new book provides a unified, in-depth, readable introduction to the multipredictor regression methods most widely used in biostatistics: linear models for continuous outcomes, logistic models for binary outcomes, the Cox model for right-censored survival times, repeated-measures models for longitudinal and hierarchical outcomes, and generalized linear models for counts and other outcomes.Treating these topics together takes advantage of all they have in common. The authors poi...

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practition...