Tal Strategy and Statistics in Clinical Trials

A Non-Statisticians Guide to Thinking, Designing and Executing
1. Auflage 2011
ISBN: 978-0-12-386992-0
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 278 Seiten

Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties. The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size. This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students. - Enables non-statisticians to better understand research processes and statistics' role in these processes - Offers real-life case studies and provides a practical, 'how to' guide to biomedical R&D - Delineates the statistical building blocks and concepts of clinical trials - Promotes effective cooperation between statisticians and important other parties

Autoren/Hrsg.

Tal, Joseph

Inhaltsverzeichnis

1;Front Cover;1
2;Strategy and Statistics in Clinical Trials: A Non-Statistician’s Guide to Thinking, Designing, and Executing;4
3;Copyright;5
4;Table of Contents;6
5;Introduction: Thinking, Designing, Executing;8
6;Chapter 1: Clinical Development and Statistics: The General View;12
6.1;Introduction;12
7;Chapter 2: Questions For Planning Trials;28
7.1;Introduction;28
8;Chapter 3: Medical Product Attributes;36
8.1;Introduction;36
9;Chapter 4: Setting Research Objectives;46
9.1;Introduction;46
10;Chapter 5: Statistical Thinking;64
10.1;Introduction: A Mental Activity;64
11;Chapter 6: Estimation;78
11.1;Introduction: Fact and Fiction;78
12;Chapter 7: From Description to Testing: A Beginning;88
12.1;Introduction;89
13;Chapter 8: Statistical Significance, Explanation, and Prediction;102
13.1;Introduction: Overview and Limitations;103
14;Chapter 9: Exploratory and Confirmatory Clinical Trials;122
14.1;Introduction: An Unlikely Story;122
15;Chapter 10: One, Two, Three Testing: Hypothesis Testing and Multiplicity;146
15.1;Introduction: The Shaking Palsy;146
16;Chapter 11: Elements of Clinical Trial Design I: Putting It Together;166
16.1;Introduction: The First Steps;166
17;Chapter 12: Elements of Clinical Trial Design II;190
17.1;Introduction: Methods for Avoiding Bias;191
18;Chapter 13: Endpoints;214
18.1;Introduction: A Humanitarian and His Machine;215
19;Chapter 14: Sample Size;240
19.1;Introduction: A Simple Study;240
20;Chapter 15: Concluding Remarks;256
21;Glossary;260
22;Index;272