Principles and Practice of Clinical Research
- 1st Edition - January 24, 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
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.
@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
Clinicians and clinical researchers
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
- Edition: 1
- Published: January 24, 2002
- Language: English
JG
John I. Gallin
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.
Affiliations and expertise
Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USARead Principles and Practice of Clinical Research on ScienceDirect