Principles and Practice of Clinical Research

ISBN-10: 0123821673
ISBN-13: 9780123821676
Edition: 3rd 2012
List price: $75.99 Buy it from $59.02 Rent it from $36.23
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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  More...

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Book details

List price: $75.99
Edition: 3rd
Copyright year: 2012
Publisher: Elsevier Science & Technology
Publication date: 7/10/2012
Binding: Hardcover
Pages: 796
Size: 8.50" wide x 10.87" long x 1.75" tall
Weight: 5.434
Language: English

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 ResearchAddresses the vast opportunities for translation of basic science observations to the bedside through clinical researchDelves into data management and addresses how to collect data and use it for discoveryContains valuable, up-to-date information on how to obtain funding from the federal government

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

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