Principles and Practice of Clinical Research

1st Edition

Print ISBN: 9780122740657
eBook ISBN: 9780080539539
Imprint: Academic Press
Published Date: 14th January 2002
Page Count: 490
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Table of Contents

A Historical Perspective on Clinical Research The Earliest Clinical Research The Greek and Roman Influence Middle Ages and Renaissance Seventeenth Century Eighteenth Century Nineteenth Century Twentieth Century and Beyond

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 Prepar


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© Academic Press 2002
Academic Press
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