Principles and Practice of Clinical Research

Edited by

  • John Gallin, M.D., Director, NIH Clinical Center and NIH Associate Director for Clinical Research, Bethesda, MD
  • Frederick Ognibene, 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

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.
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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


Book information

  • Published: April 2007
  • ISBN: 978-0-12-369440-9


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

Table of Contents

•A Historical Perspective on Clinical ResearchETHICAL, 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 MediaBIOSTATISTICS 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 LifeTECHNOLOGY 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 Review Process•Clinical Research from the Industry Perspective•Human Genome Project, Genomics, and Clinical Research