Principles and Practice of Clinical Research - 2nd Edition - ISBN: 9780123694409, 9780080489568

Principles and Practice of Clinical Research

2nd Edition

Editors: John Gallin Frederick Ognibene
Hardcover ISBN: 9780123694409
eBook ISBN: 9780080489568
Imprint: Academic Press
Published Date: 24th April 2007
Page Count: 448
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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.

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


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

Table of Contents




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


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


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


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


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


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


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


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


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


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


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


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


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


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


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




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About the Editor

John Gallin

Affiliations and Expertise

Director, NIH Clinical Center and NIH Associate Director, Clinical Research, Bethesda, MD, USA

Frederick 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, USA


PRAISE FOR THE FIRST EDITION: "...much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institutional libraries..." —THE NEW ENGLAND JOURNAL OF MEDICINE " really is a step-by-step DIY book for the uninitiated proposal writer. Full of practical advice, top tips and the ever-useful 'Supplemental reading' section, it even has a sample face sheet and a study design 'tick list'." -IMMUNOLOGY NEWS