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

Details

No. of pages:
490
Language:
English
Copyright:
© 2002
Published:
Imprint:
Academic Press
eBook ISBN:
9780080539539
Print ISBN:
9780122740657

About the editors

John Gallin

Affiliations and Expertise

M.D., Director, NIH Clinical Center and NIH Associate Director, Clinical Research, Bethesda, MD, USA

John Gallin

Affiliations and Expertise

M.D., Director, NIH Clinical Center and NIH Associate Director, Clinical Research, Bethesda, MD, USA