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PRINCIPLES & PRACTICE OF CLINICAL RESEARCH 3e(hb)2012
Author: JOHN I. GALLIN
ISBN: 9780123821676
Year: 2012
Publisher: ELSEVIER INC. USA
Category: GENERAL PRACTICE
Edition: 3
Format: Hard Cover
Language: English
Pages: 648
 ABOUT THE TITLE
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.

Key Features

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

Author: John Gallin
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 TABLE OF CONTENTS
A Historical Perspective on Clinical Research
Part I- Ethical, Regulatory and Legal Issues
Ethical Principles in Clinical Research
Researching a Bioethical Question
Integrity in Research: Individual & Institutional Responsibility
Institutional Review Boards
The Role of Independent Institutional Review Boards
The Regulation of Drugs and Biological Products by the Food and Drug Administration
Data Management in Clinical Trials
Data and Safety Monitoring Boards
Unanticipated Risk in Clinical Research
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
Accreditation of Human Research Protection Programs
The Role and Importance of Clinical Trials Registries
The Clinical Researcher and the Media
Clinical Research: A Patient Perspective
Part II- Biostatistics and Epidemiology
Design of Observational Studies
Design of Clinical Studies and Trials
Issues in Randomization
Overview of Hypothesis Testing
Introduction to Sample Size Calculation and Power
An Introduction to Survival Analysis
Intermediate Topics in Biostatistics
Measures of Function and Health-Related Quality of Life
Large Clinical Trials and Registries: Clinical Research Institutes
Meta-analysis of Clinical Trials
Using Large Datasets for Population-based Health Research
Development and Conduct of Studies
Part III- Technology Transfer, Protocol Development, and Funding
Overview of Technology Development
Patents and Patent Licenses
Writing a Protocol
Evaluating a Protocol Budget
Clinical Research Data: Characteristics, Representation, Storage and Retrieval
Management of Patient Samples and Specimens
Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health
Peer Review Process
Clinical Research from the Industry Perspective
The Role of Private Foundations in the Support and Funding of Clinical Research
Use of Questionnaires and Patient Surveys in Clinical Research
Integration of Specialized Research Services into Clinical Laboratory Operations
Use of Imaging Tools and Techniques
Role of Blood Bank and Transfusion Medicine in Clinical Research
Clinical Pharmacology and its Role in Pharmaceutical Development
Career Paths in Clinical Research
Clinical Research Nursing: A New Domain of Practice
Clinical Research in a Community-based Setting
Issues and Challenges for Clinical Research in International Settings
Power of an Undiagnosed Disease Program in a Clinical Research Enterprise
Human Genome Project, Genomics, and Clinical Research
Harnessing Information Utilizing Genomic Platforms
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