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Statistical Issues in Drug Development

Statistical Issues in Drug Development

Stephen S. Senn

ISBN: 978-0-470-86665-8

Sep 1997

442 pages

Select type: E-Book

$120.99

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Description

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.
Aus dem Inhalt:
SECTION 1: Introduction;
A Brief History of Statistics;
Design and Interpretation of Clinical Trials as seen by a Statistician;
Probability, Bayes and P-Values;
The work of the Statistician;
SECTION 2: (Controversial topics in drug development) Allocating treatment to patients in clinical trials;
Using covariate information;
Sub-group analysis;
The problem of multiplicity;
Concerning intention to treat;
One sided and two sided tests;
Determining sample size;
Active control equivalence studies;
Multi-centre trials and meta-analysis;
Sequential trials;
Cross-over trials;
N-of-1 trials;
Dose-finding;
Bioequivalence studies;
Pharmacokinetic studies;
Project prioritisation;
Statistical problems in drug monitoring;
Appendix;
Subject Index;
Author Index.