Principles and Practice of Clinical Research

2nd Edition

Editors: John Gallin Frederick Ognibene
Hardcover ISBN: 9780123694409
eBook ISBN: 9780080489568
Imprint: Academic Press
Published Date: 24th April 2007
Page Count: 448
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Institutional Access


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.

Key Features

*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


All individuals engaged in clinical research both student and researcher as well as physicians, dental investigators, PhD basic scientists, and members of allied health professions

Table of Contents

•A Historical Perspective on Clinical Research

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 Management in Clinical Trials •Unanticipated Risks in Clinical Research •The Regulation of Drugs and Biological Products by the Food and Drug Administration •Legal Issues •Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research •National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research •Clinical Research: A Patient Perspective •The Clinical Researcher and the Media

BIOSTATISTICS AND EPIDEMIOLOGY •An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation •Design and Conduct of Observational Studies and Clinical Trials •Small Clinical Trials •Large Clinical Trials and Registries - Clinical Research Institutes •Using Secondary Data in Statistical Analysis •An Introduction to Survival Analysis •Measures of Function and Health-Related Quality of Life

TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES •Overview of Technology Development •Technology Transfer •Writing a Protocol •Evaluating a Protocol Budget •Data Management in Clinical Research: General Principles and a Guide to Sources •Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Re


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© Academic Press 2007
Academic Press
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About the Editor

John Gallin

Affiliations and Expertise

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

Frederick Ognibene

Affiliations and Expertise

MD, MCCM, FACP, Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center and Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA


PRAISE FOR THE FIRST EDITION: "...much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institutional libraries..." —THE NEW ENGLAND JOURNAL OF MEDICINE " really is a step-by-step DIY book for the uninitiated proposal writer. Full of practical advice, top tips and the ever-useful 'Supplemental reading' section, it even has a sample face sheet and a study design 'tick list'." -IMMUNOLOGY NEWS