A Concise Guide to Clinical Trials [Paperback]
Author: Allan Hackshaw | Language: English | ISBN: 1405167742 | Format: PDF, EPUB
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A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations.
This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at:
- Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials
- Health professionals who wish to conduct their own trials, or participate in other people’s studies
- People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies
- Paperback: 224 pages
- Publisher: BMJ Books; 1 edition (April 27, 2009)
- Language: English
- ISBN-10: 1405167742
- ISBN-13: 978-1405167741
- Product Dimensions: 0.5 x 6.1 x 9 inches
- Shipping Weight: 11.4 ounces (View shipping rates and policies)
- Amazon Best Sellers Rank: #1,227,174 in Books (See Top 100 in Books)
1 Fundamental concepts.
2 Types of outcome measures and understanding them.
3 Design and analysis of phase I trials.
4 Design and analysis of phase II trials.
5 Design of phase III trials.
6 Randomisation.
7 Analysis and interpretation of phase III trials.
8 Systematic reviews and meta-analyses.
9 Health-related Quality of Life and Health Economic Evaluation.
10 Setting up, conducting and reporting trials.
11 Regulations and guidelines.
Reading list
When clinical trials are published in scientific journals, the authors should disclose their potential conflicts of interests. Here is mine: to my great benefit, I attended one of the courses organized by Allan Hackshaw at the Graduate School of University College London in order to provide a four-day introduction to clinical trials. I was surprised to discover how many students needed to conduct one of these for their doctoral dissertations, with just an elementary understanding of what a clinical trial is. Hackshaw's concise guide achieves two goals: it shows how complex clinical trials can be and yet provides clues to solve many of the difficulties you will probably find.
This is not a textbook, but a field guide: Hackshaw presents what practitioners do in a trial, stage by stage. The theory is kept to a minimum and is presented through examples, often drawn from real trials. If you do not have time to take a thorough course in statistics, you will find here the quickest possible introduction to the main concepts used in real medical publications. This concise guide will show you what you need to know in order to conduct your own trial: you will see the forest, so you can decide what you need to learn in order to conduct your own trial. At every stage, the author illustrates the choices you will have to make. Once you identify your potential dilemmas, you will probably need additional readings to design and interpret your trial and Hackshaw provides many useful suggestions in the references.
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