
Principles and Practice of Clinical Research
Academic Press
3rd Edition
Published on 10. July 2012
Book
Hardback
796 pages
978-0-12-382167-6 (ISBN)
Shipment within 15-20 days
Description
The third 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.
Reviews / Votes
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
"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition. Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research...This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals." --Journal of Clinical Research Best Practices, May 2013
More details
Edition
3rd edition
Language
English
Place of publication
San Diego
United States
Publishing group
Elsevier Science Publishing Co Inc
Target group
Professional and scholarly
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
Product notice
Laminated cover
Dimensions
Height: 284 mm
Width: 222 mm
Thickness: 32 mm
Weight
1860 gr
ISBN-13
978-0-12-382167-6 (9780123821676)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions

John I. Gallin | Frederick P. Ognibene | Laura Lee Johnson
Principles and Practice of Clinical Research
Book
12/2017
4th Edition
Academic Press
€116.50
Shipment within 15-20 days
Additional editions

John I. Gallin MD | Frederick P. Ognibene
Principles and Practice of Clinical Research
E-Book
07/2012
3rd Edition
Academic Press
€94.95
Available for download
Previous edition

John I. Gallin | Frederick P. Ognibene
Principles and Practice of Clinical Research
Book
06/2007
2nd Edition
Academic Press
€90.52
Article exhausted; check for reprint
Persons
Dr. John Gallin was appointed to the dual roles of National Institutes of Health (NIH) Associate Director for Clinical Research and inaugural Chief Scientific Officer, the Clinical Center in August 2016. He served as the Director NIH Clinical Center from 1994-2017 after serving 9 years as Scientific Director of the National Institute of Allergy and Infectious Diseases (NIAID) and 12 years as Chief of the Laboratory of Host Defenses. During his tenure as Director of the NIH Clinical Center, Dr. Gallin helped to lead the design, construction, and activation of the Mark O. Hatfield Clinical Research Center, the largest hospital in the world totally dedicated to clinical research. He also oversaw the establishment of a new curriculum for clinical research training, now offered globally reaching over 25,000 students annually in 168 countries, and the development of new information systems for biomedical, translational and clinical research. In 2011, Dr. Gallin accepted, on behalf of the NIH Clinical Center, the Lasker-Bloomberg Public Service Award for its rich history of medical discovery through clinical research. His primary research interests are rare immune disorders of phagocytes, with a focus on chronic granulomatous disease (CGD). His laboratory described the genetic basis for several forms of CGD and other disorders of phagocytes and has done pioneering research that has reduced life-threatening bacterial and fungal infections in patients with these disorders. He has published more than 380 articles in scientific journals and edited two textbooks - Inflammation, Basic Principles and Clinical Correlates (Lippincott, Williams, and Wilkins, 1999, 3rd edition) and Principles and Practice of Clinical Research (Academic Press, 4th edition 2018). He has received numerous awards and honors for his accomplishments and in 2022 received the Weill Cornell Medical College Alumni Award of Distinction, the medical college's most prestigious alumni award. Dr. Gallin is a member of the American Society for Clinical Investigation, the Association of American Physicians, the National Academy of Medicine of the National Academy of Sciences, a Master of the American College of Physicians, and a Fellow of the Royal College of Physicians-London. He retired from his administrative positions in 2023 and is now an Adjunct Senior Investigator at NIH in the Laboratory of Clinical Immunology and Microbiology in the National Institute of Allergy and Infectious Diseases.
Editor
Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USA
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
Content
*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 Review Process
*Clinical Research from the Industry Perspective
*Human Genome Project, Genomics, and 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 Review Process
*Clinical Research from the Industry Perspective
*Human Genome Project, Genomics, and Clinical Research