Principles and Practice of Clinical Research
- 1st Edition - January 14, 2002
- Editor: John I. Gallin
- Language: English
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is div… Read more
Description
Description
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research.
Key features
Key features
@introbul:Key Features
@bul:* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research
@bul:* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research
Readership
Readership
Clinicians and clinical researchers
Table of contents
Table of contents
A Historical Perspective on Clinical Research
The Earliest Clinical Research
The Greek and Roman Influence
Middle Ages and Renaissance
Seventeenth Century
Eighteenth Century
Nineteenth Century
Twentieth Century and Beyond
Part I: 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
Part II: 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
Part III: 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
Getting the Funding You Need to Support Your Research: Successfully Navigating the NIH Peer Review Process for Grants
The Earliest Clinical Research
The Greek and Roman Influence
Middle Ages and Renaissance
Seventeenth Century
Eighteenth Century
Nineteenth Century
Twentieth Century and Beyond
Part I: 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
Part II: 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
Part III: 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
Getting the Funding You Need to Support Your Research: Successfully Navigating the NIH Peer Review Process for Grants
Product details
Product details
- Edition: 1
- Published: January 14, 2002
- Language: English
About the editor
About the editor
JG
John I. Gallin
Dr.John Gallin served as Director of the NIH Clinical Center (1994–2017) and later as NIH Associate Director for Clinical Research. He led the development of the Mark O. Hatfield Clinical Research Center and global training programs. His research focused on rare immune disorders, and he published extensively. Dr. Gallin was the founder of the Introduction to the Principles and Practice of Clinical Research course at the NIH. Dr. Gallin passed away in 2024.
Affiliations and expertise
Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USAView book on ScienceDirect
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