Statistics, Health Policy, Medical Research, Pharmacology
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Overview
This unique handbook satisfies the essential information needs of professionals who are responsible for planning, running, and analyzing industrial clinical trials in the pharmaceutical industry, offering - for the first time - clear-cut guidance on the experimental design and general planning of the trials, as well as the basic statistics needed to analyze the results. Requiring no background in experimental design or statistical analysis, and only minimal knowledge of algebra, Planning Pharmaceutical Clinical Trials enables you to conform as closely as possible to the principles and procedures of good scientific experimentation in carrying out clinical trials, whether you're a physician, biologist, chemist, pharmacologist, clinical research associate, or nurse. Using examples throughout, the book introduces the subject of experimental design in clinical trials and its relationship to statistical analysis. It outlines the nature and purposes of trials, examines the basics of good clinical trial design, describes the role of the Food and Drug Administration with regard to trials, and reveals how you can work with the FDA to satisfy its testing requirements. You're then taken systematically through every stage of the scientific aspects of trial planning - from defining your objectives and deciding which factors are to be tested . . . through estimating sample size, choosing a design, and devising a randomization plan . . . to writing the protocol and preparing the clinical report forms. Planning Pharmaceutical Clinical Trials goes on to provide you with a detailed understanding of the nature and use of the most common experimental designs used in clinical trials in language easily accessible to nonstatisticians. Here, you'll discover the randomization procedures needed for a variety of one-factor parallel, multifactor parallel, parallel factorial, and changeover designs. The book then offers you a brief background in elementary applied statistical analysis, whicEditorials
Booknews
A handbook for professionals who are responsible for planning, running, and analyzing industrial clinical trials in the pharmaceutical industry, offering guidance on the experimental design and general planning of the trials, as well as the basic statistics needed to analyze the results. Requires no background in experimental design or statistical analysis, and only minimal knowledge of algebra. Annotation c. Book News, Inc., Portland, OR (booknews.com)Book Details
Published
November 15, 1993
Publisher
Wiley, John & Sons, Incorporated
Pages
560
Format
Hardcover
ISBN
9780471622444