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Principles and Practice of Clinical Research
- 2nd Edition - April 28, 2011
- Editors: John I. Gallin, Frederick P Ognibene
- Language: English
- eBook ISBN:9 7 8 - 0 - 0 8 - 0 4 8 9 5 6 - 8
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… Read more
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Request a sales quoteThe 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
*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
All individuals engaged in clinical research both student and researcher as well as physicians, dental investigators, PhD basic scientists, and members of allied health professions
Preface
Acknowledgements
Contributors
Chapter 1: A historical perspective on clinical research
1. The Earliest Clinical Research
2. The Greek and Roman Influence
3. Middle Ages and Renaissance
4. Seventeenth Century
5. Eighteenth Century
6. Nineteenth Century
7. Twentieth Century and Beyond
References and Notes
Part I: Ethical, regulatory, and legal issues
Chapter 2: Ethical principles in clinical research
1. Distinguishing Clinical Research From Clinical Practice
2. What Does Ethics Have to Do With Clinical Research?
3. History of Ethical Attention to Clinical Research
4. Codes of Research Ethics and Regulations
5. Ethical Framework for Clinical Research
6. Ethical Considerations in Randomized Clinical Trials
7. Conclusion
References
Chapter 3: Researching a Bioethical Question
1. Types of Bioethical Issues
2. Types of Bioethical Research Methodologies
3. Examples of Important Bioethical Research
4. Special Considerations in Bioethical Research
References and Notes
Chapter 4: Integrity in research
1. Guidelines for the Conduct of Research
2. Scientific Integrity and Misconduct
3. Mentor-Trainee Relationships
4. Data Acquisition, Management, Sharing, and Ownership
5. Research Involving Human and Animal Subjects
6. Collaborative Science
7. Conflict of Interest and Commitment
8. Peer Review
9. Publication Practices and Responsible Authorship
References
Chapter 5: Institutional review boards
1. Historical, Ethical, and Regulatory Foundations of Current Requirements for Research Involving Human Subjects
2. Institutional Review Boards
3. Clinical Researchers and Irbs
4. The Current Irb System Under Evaluation
5. Conclusion
References and Notes
Chapter 6: Data and safety monitoring boards
1. Description of the Data and Safety Monitoring Board
2. Data and Safety Monitoring Board Functions
3. Data and Safety Monitoring Board Decision Making
4. Examples
5. Conclusions
References
Chapter 7: Data management in clinical trials
1. The Research Team
2. Planning the Trial
3. Where Are Data?
4. Who Can Collect Data?
5. Site Initiation Visit
6. Informed Consent
7. Eligibility
8. Registration
9. What Data Do you Collect?
10. Treatment Plan
11. Concurrent Therapy
12. Adverse Event Monitoring
13. Routine Monitoring Visits
14. Audit Trail
15. Electronic Database
16. Summary
References
Chapter 8: Unanticipated risk in clinical research
1. The Reasons
2. The Drug
3. The Target
4. The Trials
5. Cassandra Revealed
6. Extended Studies
7. Fiau Toxicity
8. Reassessing the Preclinical Studies
9. Research Oversight
10. The Investigations Begin
11. Scientific Misconduct
12. The Fda
13. The National Institutes of Health
14. The Institute of Medicine
15. The Media
16. The Congress
17. The Law
18. Epilogue
Chapter 9: The regulation of drugs and biological products by the food and drug administration
1. Introduction
2. Background
4. Drug and Biologic Life Cycle
5. Summary
Chapter 10: Legal Issues
1. Legal Issues Related to Informed Consent for Clinical and Research Care
2. Advance Directives/Substitute Consent
3. Children in Research
4. Medical/Research Records
5. Confidentiality
6. Legal Liability
7. Conflict of Interest
8. Authorship/Rights in Data
Appendix: NIH advance directive for health care and medical research participation
Instructions
Issues for Consideration and Discussion
Medical Conditions Relevant to End-of-Life Decision Making
Treatment Options
Kinds of Research
Chapter 11: Rules to prevent conflict of interest for clinical investigators conducting human subjects research
1. Preventing Conflict of Interest in Clinical Research in the Nih Intramural Research Program
2. Preventing Conflict of Interest By Members of Institutional Review Boards
References
Appendix: A guide to preventing financial and non-financial conflicts of interest in human subjects research at NIH
I. What Are a Clinical Investigator’s Potential Conflicts of Interest?
II. To Whom Does the Guide Apply?
III. Examples of Investigator and Irb and Dsmb Member Financial Conflicts of Interest
IV. Examples of Non-Financial Real Or Apparent Conflicts of Interest for Irb and Dsmb Members
V. Nih’s System to Assist in Identifying and Preventing Financial Conflicts for Investigators in Clinical Research
VI. Irb and Dsmb Clearance for Coi
VII. Nih Intellectual Property and Royalties
Protocol Conflict of Interest Statement (Appendix 1)
Chapter 12: National institutes of health policy on the inclusion of women and minorities as subjects in clinical research
1. Nih Policy
2. Focus on Scientific Considerations
3. Role of the Nih Office of Research on Women’s Health
4. Role of Peer Review
5. Role of the Institutional Review Board
6. Role of Volunteers and Their Communities
7. Demographic Data on Subject Enrollment
8. Women of Childbearing Potential, Pregnant Women, and Children
9. Future Questions
10. Conclusions
References and Notes
Chapter 13: Clinical research
1. The Patient-Scientist Partnership
2. Walking Away: Why Patients Refuse to Participate in Clinical Trials
3. The Trial Begins: Understanding the Patient Experience
4. Understanding the Caregiver
5. The Role of Palliative Care
6. Managing Difficult News
7. Effective Patient Communications: Recommendations and Considerations
8. The Assertive Patient: Ally in Scientific Research
9. Conclusion
Chapter 14: The Clinical Researcher and the Media
1. What Makes News in Science and Medicine?
2. Why Talk to Reporters?
3. Why Reporters Want to Talk to You
4. Why you Should Talk to Reporters
5. Engaging the Media: the Process
6. a Word About E-Mail and the Internet
7. The Interview
8. What If you Are Misquoted?
9. What the Public Does Not Know About Science
10. Unexpected Questions
11. When the News is Not Good
12. a Word About Investigative Reporters
13. The Freedom of Information Act
14. Embargoes
15. The Ingelfinger Rule
16. Clinical Alerts
17. When to Contact Your Communications Office
18. Conclusion
Part II: Biostatistics and epidemiology
Chapter 15: An introduction to biostatistics
1. Introduction
2. Issues in Randomization
3. Overview of Hypothesis Testing
4. Sample Size and Power
5. Special Considerations
6. Conclusion
References
Chapter 16: Design and conduct of observational studies and clinical trials
1. Types of Epidemiologic Study Designs
2. Ecological (Correlational) Studies
3. Case Reports and Case Series
4. Prevalence Surveys Or Cross-Sectional Studies
5. Case-Control Studies
6. Prospective Or Longitudinal Cohort Studies
7. Causal Inference in Observational Studies
8. Clinical Trials
9. Conduct of Epidemiologic Studies: the Study Protocol
References
Chapter 17: Small Clinical Trials
1. Introduction
2. Where We Are in the Short History of Controlled Clinical Trials
3. Explanatory Versus Pragmatic Orientation in Clinical Trials: Implications for Study Design
4. Issues in Small Clinical Trials That Examine Both Disease Mechanism and Treatment Efficacy
5. Placebo Responses in Clinical Trials
6. Conclusion
References
Chapter 18: Large clinical trials and registries— clinical research institutes
1. Introduction
2. History
3. Phases of Evaluation of Therapies
4. Critical General Concepts
5. Expressing Clinical Trial Results
6. Concepts Underlying Trial Design
7. General Design Considerations
8. Legal and Ethical Issues
9. Hypothesis Formulation
10. Publication Bias
11. Statistical Considerations
12. Meta-Analysis and Systematic Overviews
13. Understanding Covariates and Subgroups
14. Therapeutic Truisms
15. Study Organization
16. Integration Into Practice
17. Controversies and Personal Perspective
18. The Future
References
Chapter 19: Using secondary data in statistical analysis
1. Techniques of Meta-Analysis
2. Meta-Analysis of Clinical Trials of Anti-Inflammatory Agents in Sepsis
3. Conclusions
References
Chapter 20: An Introduction to Survival Analysis
1. Features of Survival Data
2. Survival Function
3. Special Considerations
4. Conclusion
Chapter 21: Measures of function and health-related quality of life
1. Introduction to Function and Quality of Life
2. Definition of Quality of Life
3. Health-Related Quality of Life Measures
4. Other Instruments to Consider
5. Importance of Quality of Life Measures for Health Care
Part III: Technology transfer, protocol development, funding and other issues
Chapter 22: Overview of technology development
1. Introduction
2. Scenario: Disasters Waiting to Happen
3. The First and Biggest Mistake: Signing the Agreements
4. Agreements Not to Disclose: Trade Secrets and the Confidential Disclosure Agreement
5. Agreements to Transfer Materials
6. Collaboration and Inventions: the Cooperative Research and Development Agreement
7. Proprietary Materials: the Materials Crada
8. Trademarks and Copyrights for the Government Scientist
9. Conclusion
References and Notes
Chapter 23: Technology transfer
1. What is Technology Transfer?
2. Patents As Intellectual Property
3. Rationale for Using Patents
4. Historical Beginnings of Patents
6. 35 U.S.C 102: Concept of Novelty
7. 35 Usc 103: Concept of Obviousness
8. More is Needed to Establish the Quid Pro Quo
9. 35 U.S.C. 112 and the Need to Know
10. Procedures for Prosecuting a Patent Application At the Uspto
11. Obtaining Foreign Patents
12. The Nih Path to Filing Patent Applications
13. The Nih Licensing Process
14. Other Ott Functions
15. Conclusion: the Measure of Nih Technology Transfer is Its Success
References
Chapter 24: Writing a protocol
1. Types of Protocols
2. Writing a Protocol
3. What Happens to Your Protocol?
4. Essential Elements to the Protocol
Chapter 25: Evaluating a protocol budget
1. Introduction
2. Requirements
3. Establishing a Protocol Budget
4. Summary
Chapter 26: Data management in clinical research
1. Introduction
2. The Dimensions of Data
3. Kinds of Data
4. General Considerations
5. Documents That Govern Data Management
5.1. Hipaa
6. Summary
References
Chapter 27: Getting the funding you need to support your research
1. Overview of Nih
2. The Nih Peer Review Process for Grants
3. Hints for Preparing Better Grant Applications
3.9. Other Important Parts of the Application
4. Nih Award Mechanisms for Support of Clinical Researchers At Various Stages in Their Careers
5. Other Nih Programs for Clinical Researchers
6. New Directions and Initiatives At Nih
7. How to Stay Informed About the Nih Peer Review System
Chapter 28: Clinical research from the industry perspective
1. Components of the Pharmaceutical Industry
2. Issues Impacting Industry Clinical Research
3. Industry Outlook
4. Summary
References
Chapter 29: Human genome project, genomics, and clinical research
1. Overview
2. Genetic Models
3. Complex Trait Dissection
4. Sample Collection and Informed Consent
5. Approach to Genotyping
6. Linkage Analysis (Parametric)
7. Nonparametric Analysis
8. Association and Linkage Disequilibrium
9. Gene Identification
10. Integration of Genetics Into Medical Practice
11. Summary
References
Index
- No. of pages: 448
- Language: English
- Edition: 2
- Published: April 28, 2011
- Imprint: Academic Press
- eBook ISBN: 9780080489568
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, MDFO
Frederick P Ognibene
Affiliations and expertise
MD, MCCM, FACP, Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center and Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health, Bethesda, MD, USARead Principles and Practice of Clinical Research on ScienceDirect