Principles and Practice of Clinical Research

Other | January 1, 2002

byGallin, John I., John I. Gallin

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Principles and Practice of Clinical Researchis a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research.

This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research.

Key Features
* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research

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From the Publisher

Principles and Practice of Clinical Researchis a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research.This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is desi...

Format:OtherDimensions:490 pages, 1 × 1 × 1 inPublished:January 1, 2002Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:008053953X

ISBN - 13:9780080539539

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Extra Content

Table of Contents

Preface.
Acknowledgements.
Historical Perspective and Introduction.

Part I: Ethical, Regulatory and Legal Issues
Ethical Principles in Clinical Research.
Researching a Bioethical Question.
Integrity in Research: Individual and Institutional Responsibility.
Institutional Review Boards.
Data and Safety Monitoring Boards.
Data and Data Management in Clinical Trials.
Unanticipated Risk in Clinical Research.
The Regulation of Drugs and Biological Products by the Food and Drug Administration.
Legal Issues.
NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research.

Part II: Biostatistics and Epidemiology
An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size.
Design and Conduct of Observational Studies and Clinical Trials.
Small Clinical Trials.
Large Clinical Trials - Clinical Research Institutes.
Using Secondary Data in Statistical Analysis.
An Introduction to Survival Analysis.
Measures of Function and Health Related to Quality of Life.
Economic Analysis and Clinical Research.

Part III: Technology Transfer, Protocol Development and Funding
Overview of Technology Development.
Technology Transfer.
Telemedicine Systems.
Animal Models of Human Disease.
Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine.
Preparing Scientific Images for Publication and Display.
Writing a Clinical Protocol - The Mechanics.
Navigating the Peer Review Process for Grants.