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Principles and Practice of Clinical Research

ISBN-10: 012369440X

ISBN-13: 9780123694409

Edition: 2nd 2007

Authors: John I. Gallin, Frederick P. Ognibene

List price: $120.00
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Description:

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
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Book details

List price: $120.00
Edition: 2nd
Copyright year: 2007
Publisher: Elsevier Science & Technology Books
Publication date: 6/6/2007
Binding: Hardcover
Pages: 448
Size: 8.50" wide x 11.00" long x 1.00" tall
Weight: 2.750
Language: English

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