Principles and Practice of Clinical Research
Edited by- John Gallin, Director, National Institutes of Health Clinical Center Head, Clinical Pathophysiology Section, Laboratory of Host Defenses,National Institute of Allergy and Infectious Diseases Bethesda, MD, USA
- Frederick Ognibene, Director, Office of Clinical Training and Medical Education, Clinical Center, National Institutes of Health, Bethesda, MD, USA
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.
Audience
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
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Published: April 2007
Imprint: Academic Press
ISBN: 978-0-12-369440-9
Reviews
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PRAISE FOR THE FIRST EDITION: "...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional libraries..." THE NEW ENGLAND JOURNAL OF MEDICINE "...it 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
Contents
- A Historical Perspective on Clinical ResearchETHICAL, REGULATORY, AND LEGAL ISSUESEthical 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 EPIDEMIOLOGYAn 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 ISSUESOverview of Technology DevelopmentTechnology TransferWriting a ProtocolEvaluating a Protocol BudgetData Management in Clinical Research: General Principles and a Guide to SourcesGetting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review ProcessClinical Research from the Industry PerspectiveHuman Genome Project, Genomics, and Clinical Research
