Principles and Practice of Clinical Research

by Gallin, John; Ognibene, Frederick

• ISBN13: 9780123694409
• ISBN10: 012369440X
• Edition: 2nd
• Format: Hardcover
• Copyright: 2007-04-27
• Publisher: HARCOURT BRACE & JOVANOVICH

Summary

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Table of Contents

Preface

Acknowledgements

Historical Perspective and Introduction

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

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

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

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