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Principles and Practice of Clinical Research
 
 

Principles and Practice of Clinical Research, 3rd Edition

 
Principles and Practice of Clinical Research, 3rd Edition,John Gallin,Frederick Ognibene,ISBN9780123821676
 
 
 

Gallin   &   Ognibene   

Academic Press

9780123821676

9780123821683

800

276 X 216

A comprehensive reference that addresses the theoretical and practical issues involved in conducting clinical research

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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

Description

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.

Readership

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

John Gallin

Affiliations and Expertise

M.D., Director, NIH Clinical Center and NIH Associate Director for Clinical Research, Bethesda, MD

View additional works by John I. Gallin

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

Principles and Practice of Clinical Research, 3rd Edition

Contributors

Preface

Acknowledgments

Chapter 1. A Historical Perspective on Clinical Research

The Earliest Clinical Research

Greek and Roman Influence

Middle Ages and Renaissance

Seventeenth Century

Eighteenth Century

Nineteenth Century

Twentieth Century and Beyond

Acknowledgment

Summary Questions

REFERENCES

Part I Ethical, Regulatory and Legal Issues

Chapter 2. Ethical Principles in Clinical Research

Distinguishing Clinical Research from Clinical Practice

What does Ethics have to do with Clinical Research?

History of Ethical Attention to Clinical Research

Codes of Research Ethics and Regulations

Ethical Framework for Clinical Research

Ethical Considerations in Randomized Clinical Trials

Conclusion

Summary Questions

REFERENCES

Chapter 3. Researching a Bioethical Question

Types of Bioethical Issues

Types of Bioethical Research Methodologies

Examples of Important Bioethical Research

Special Considerations in Bioethical Research

REFERENCES AND NOTES

Chapter 4. Integrity in Research

Guidelines for the Conduct of Research

Scientific Integrity and Misconduct

Mentor–Trainee Relationships

Data Acquisition, Management, Sharing, and Ownership

Research Involving Human and Animal Subjects

Collaborative Science

Conflict of Interest and Commitment

Peer Review

Publication Practices and Responsible Authorship

Acknowledgment

Summary Questions

REFERENCES

Chapter 5. Institutional Review Boards

Historical, Ethical, and Regulatory Foundations of Current Requirements for Research Involving Human Subjects

Institutional Review Boards

Clinical Researchers and IRBS

The Current IRB System Under Evaluation

Conclusion

Summary Questions

REFERENCES AND NOTES

Chapter 6. The Role of Independent Institutional Review Boards

History

Reasons to use an Independent IRB

Limitations of Independent IRBs

Selecting an Independent IRB

Working with an Independent IRB

Future Directions

Author’s Note

Resources

Summary Questions

REFERENCES

Chapter 7. The Regulation of Drugs and Biological Products by the Food and Drug Administration

Introduction

Background

Mission, Organization, and Terminology

Drug and Biologic Life Cycle

Summary Questions

Chapter 8. Data Management in Clinical Trials

The Research Team

Data Management Considerations during Protocol Design and Development

Data Collection

Auditing

Adverse Event Monitoring and Reporting

Legal And Regulatory Issues Related to Data Reporting

Follow-Up and Analysis

Record Retention

Conclusion

Summary Questions

REFERENCES

Chapter 9. Data and Safety Monitoring

Introduction

Description of the Data and Safety Monitoring Board

Data and Safety Monitoring Board Functions

Data and Safety Monitoring Board Decision Making

Examples

Conclusions

Summary Questions

REFERENCES

Chapter 10. Unanticipated Risk in Clinical Research

The Reasons

The Drug

The Target

The Trials

Cassandra Revealed

Extended Studies

Fiau Toxicity

Reassessing the Preclinical Studies

Research Oversight

The Investigations Begin

Scientific Misconduct

The FDA

The National Institutes of Health

The Institute of Medicine

The Media

The Congress

The Law

Epilogue

Acknowledgments

REFERENCES

Chapter 11. Legal Issues

Legal Issues Related to Informed Consent for Clinical and Research Care

Advance Directives/Substitute Consent

Children in Research

Medical/Research Records

Confidentiality

Legal Liability

Conflict of Interest

Authorship/Rights in Data

Summary Questions

Appendix

Instructions

Medical Record

NOTES AND REFERENCES

Further Reading

Chapter 12. Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research

Preventing Conflict of Interest in Clinical Research in the NIH Intramural Research Program

Preventing Conflict of Interest by Members of Institutional Review Boards

Appendix

Appendix 1

Summary Questions

REFERENCES

Chapter 13. National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

NIH Policy

Scientific Considerations and Implementation

Role of Peer Review

Role of the Institutional Review Board

Role of Volunteers and their Communities

Demographic Data on Subject Enrollment

Women of Childbearing Potential, Pregnant Women, and Children

What have We Learned

Conclusion

Summary Questions

REFERENCES AND NOTES

Chapter 14. Accreditation of Human Research Protection Programs

Brief History

Principles of Accreditation

What AAHRPP Expects from Organizations

What Organizations can Expect from AAHRPP

The Concept of a Human Research Protection Program

The Accreditation Standards

Summary Questions

REFERENCES

Chapter 15. The Role and Importance of Clinical Trial Registries and Results Databases

Introduction

Background

Current Policies

Registering Clinical Trials at ClinicalTrials.gov

Reporting Results to ClinicalTrials.gov

Using ClinicalTrials.gov Data

Conclusion

Summary/Discussion Questions

REFERENCES

Chapter 16. The Clinical Researcher and the Media

What Makes News In Science and Medicine?

Published Science—the Media’s Bread and Butter

Novelty

The Unexpected

Celebrity

Tragedy and Controversy

Impact

Why Talk to Reporters?

Why Reporters Want to Talk to You

Why you Should Talk to Reporters

Engaging the Media—The Process

A Word About E-Mail, the Internet, and New Media

If you Get a Call…

The Interview

What if you are Misquoted?

What the Public Does not Know About Science

Unexpected Questions

When the News is not Good

A Word About Investigative Reporters

The Freedom of Information Act (FOIA)

Embargoes

The Inglefinger Rule

Clinical Alerts

When to Contact your Institute’s/Center’s Communications Office

Conclusion

Summary Questions

Chapter 17. Clinical Research

The Patient–Scientist Partnership

Walking Away: Why Patients Refuse to Participate in Clinical Trials

The Trial Begins: Understanding the Patient Experience

Understanding the Caregiver

The Role of Palliative Care

Managing Difficult News

Effective Patient Communications: Recommendations and Considerations

The Assertive Patient: Ally in Scientific Research

Conclusion

FURTHER READING

Part II Biostatistics and Epidemiology

Chapter 18. Design of Observational Studies

Introduction

Ecological (Correlational) Studies

Case Reports and Case Series

Single Time Point Studies: Cross-Sectional Studies, Prevalence Surveys, and Incidence Studies

Case–Control Studies

Cohort Studies: Retrospective, Prospective, and Studies Nested Within a Cohort

Odds Ratios, Risk Ratios, Relative Risks, and Attributable Risk

Mistakes, Misconceptions, and Misinterpretations

Conclusions

Acknowledgments

Summary Questions

REFERENCES

Chapter 19. Design of Clinical Studies and Trials

The Purpose of Clinical Trials and Studies

Understanding the Spectrum of the Research Continuum

Clinical Trial Designs

Critical Issues in Clinical Study Design

Control Groups

Placebo Responses

Mistakes and Misconceptions

Conclusions

Acknowledgments

Summary Questions

REFERENCES

Chapter 20. Issues in Randomization

Introduction

History of the Randomized Trial

Randomization Methods

Issues in Implementation

Special Considerations

Conclusion

Acknowledgment

Summary Questions

REFERENCES

Chapter 21. Hypothesis Testing

Introduction

The Formulation of Statistical Hypotheses in the Motivating Examples

One-Sample Hypothesis Tests With Applications to Clinical Research

Two-Sample Hypothesis Tests With Applications to Clinical Research

Hypothesis Tests for the Motivating Examples

Common Mistakes in Hypothesis Testing

Misstatements and Misconceptions

Special Considerations

Conclusion

Acknowledgments

Summary Questions

REFERENCES

Chapter 22. Power and Sample Size Calculations

Introduction

Sample Size Calculations for Precision in Confidence Interval Construction

Sample Size Calculations for Hypothesis Tests: One Sample of Data

Sample Size Calculations for Hypothesis Tests: Paired Data

Sample Size Calculations for Hypothesis Tests: Two Independent Samples

Advanced Methods and Other Topics

Conclusion

Exercises

Acknowledgments

REFERENCES

Chapter 23. An Introduction to Survival Analysis

Introduction

Features of Survival Data

Survival Function

Common Mistakes

Conclusion

Summary Questions

REFERENCES

Chapter 24. Intermediate Topics in Biostatistics

1 Special Topics in Trial Design

2 Special Considerations in Data Analysis

3 Regression to the Mean

4 Diagnostic Testing

5 Special Considerations in Survival Analysis

6 Missing Data

7 Causal Inference in Observational Studies

8 Concluding Remarks

Summary Questions

Acknowledgement

REFERENCES

Chapter 25. Measures of Function and Health-related Quality of Life

Introduction to Function and Health-Related Quality of Life (HRQL) Measures

How are Function, QOL, and HRQL Measures Used?

Examples of Functional Measures and Health-Related Quality of Life Measures

Other Instruments to Consider

Importance of Quality of Life Measures for Health Care

Summary Questions

REFERENCES

Chapter 26. Large Clinical Trials and Registries—Clinical Research Institutes

Introduction

History

Phases of Evaluation of Therapies

Critical General Concepts

Expressing Clinical Trial Results

Concepts Underlying Trial Design

General Design Considerations

Legal and Ethical Issues

Hypothesis Formulation

Publication Bias

Statistical Considerations

Meta-Analysis and Systematic Overviews

Understanding Covariates and Subgroups

Therapeutic Truisms

Study Organization

Integration Into Practice

Controversies and Personal Perspective

The Future

Summary Questions

REFERENCES

Chapter 27. Meta-analysis of Clinical Trials

Techniques of Meta-Analysis

Meta-Analysis of Clinical Trials of Anti-Inflammatory Agents in Sepsis

Conclusions

Summary Questions

REFERENCES

Chapter 28. Using Large Datasets for Population-based Health Research

Introduction

Where Does the Data Come from?

Uses of Secondary Data in Health Research

Strengths

Limitations (and Solutions)

Surveys

Linking Data Sets

Ethical Considerations

Future Directions and Conclusions

Summary Questions

REFERENCES

Chapter 29. Development and Conduct of Studies

How to Choose a Study Design

Development and Importance of a Study Protocol

Equipoise

Manual of Operating Procedures

Reporting the Results

Conclusions

Acknowledgments

Summary Questions

REFERENCES

Part III Technology Transfer, Protocol Development, and Funding

Chapter 30. Overview of Technology Development

Introduction

Scenario: Disasters Waiting to Happen

The First and Biggest Mistake: Signing the Agreements

Agreements Not to Disclose: Trade Secrets and the Confidential Disclosure Agreement

Agreements to Transfer Materials

Collaboration and Inventions: The Cooperative Research and Development Agreement

Proprietary Materials: The Materials CRADA

Conclusion

Summary Questions

REFERENCES AND NOTES

Chapter 31. Patents and Patent Licenses

Introduction

Part One: Patents Generally

Core Concepts of us Patent Law

Basic Elements of the Patent Application Process

Part Two: Patents And Technology Transfer

Patenting and Licensing by Federal Agencies

Conclusion

Brief Glossary of Critical Terms in Patenting

Summary Questions

REFERENCES AND NOTES

Chapter 32. Writing a Protocol

Types of Protocols

Writing a Protocol

What Happens to your Protocol?

Essential Elements to Include in the Protocol

Summary

Summary Questions

REFERENCES

Chapter 33. Evaluating a Protocol Budget

Introduction

Requirements

Establishing a Protocol Budget

Summary

Chapter 34. Clinical Research Data

Introduction

Data as Surrogates

Types of Data

Data Standards

Data Capture, Storage, and Retrieval

Responsible Stewardship of Data

Cooperative Sharing Efforts

Summary

Summary Questions

REFERENCES

Chapter 35. Management of Patient Samples and Specimens

Successful Research Rests On A Foundation of Careful Planning

The Role of Pre-Analytic Variables in Research Using Patient Specimens

The Importance of Good Record Keeping

Specimen Tracking

Specimen Collection

Specimen Handling

Specimen Transit

Specimen Storage

Access To Patient Samples

Specimen Culling, Transfer of Collections, and Repository Closings

Summary Questions

REFERENCES

Chapter 36. Getting the Funding You Need to Support Your Research

Overview of NIH

The NIH Peer Review Process for Grants

Hints for Preparing Better Grant Applications

NIH Grant Programs for Clinical Researchers at Various Stages in their Careers

How to Stay Informed about NIH Peer Review

Chapter 37. Clinical Research from the Industry Perspective

History of the Pharmaceutical Industry

Components of the Pharmaceutical Industry

Issues Impacting Industry Clinical Research

Industry Outlook

Public–Private Opportunities

Summary Questions

REFERENCES

Chapter 38. Philanthropic Sector Support for Medical Research and Training

Introduction

Prior to 1950

1950 to Present

Alliances of Funders and Other Resources

Future Directions

Summary Questions

REFERENCES

Part IV Clinical Research Infrastructure

Chapter 39. Managing Clinical Risk and Measuring Participants’ Perceptions of the Clinical Research Process

Identifying and Managing Clinical Risk in the Clinical Research Environment

Assessing Clinical Research Participants’ Perceptions of the Clinical Research Experience

Conclusion

REFERENCES

Chapter 40. Integration of Specialized Research Services into Clinical Laboratory Operations

Introduction

Specialized Laboratory Services Developed for Clinical Research

Testing Approaches Used in Support of Clinical Research

Test Reporting

Examples of Specialized Laboratory Services Developed for Clinical Research

Summary

REFERENCES

Chapter 41. Imaging in Clinical Trials

Introduction: The Use of Imaging in Clinical Trials

Imaging Modalities

Imaging Interpretation

Imaging Core Laboratories

Incidental Imaging Findings

Risk Considerations From Imaging

Issues Regarding Sample Size

Picture Archiving and Communication System (PACS)

Role of the Imaging Specialist On the Clinical Trial Team

Summary

Summary Questions

REFERENCES

Chapter 42. Role of Blood Bank and Transfusion Medicine in Clinical Research

Introduction

Structure of the “Blood Bank”

The NIH Clinical Center’s Department of Transfusion Medicine

Summary Questions

REFERENCES

Chapter 43. Clinical Pharmacology and its Role in Pharmaceutical Development

Clinical Pharmacology as a Translational Discipline—Definition and Scope

Overview of Drug Development

Current State of Affairs in Drug Development

Contribution of Clinical Pharmacology

The Role of the Food and Drug Administration

Summary Questions

REFERENCES

Chapter 44. Career Paths in Clinical Research

Background

Student and Resident Training in Clinical Research

Clinical Research Curriculum

NIH Clinical Center Core Curriculum

Additional Educational Approaches and Support for Training

Conclusions

REFERENCES

Chapter 45. Clinical Research Nursing

Introduction

Clinical Research Nursing: A New Practice Specialty

Defining and Documenting the Specialty of Clinical Research Nursing

Legal Scope of Practice Issues

Tools to Assist a Principal Investigator in Staffing a Study

Future Considerations

Summary/Discussion Questions

REFERENCES

Chapter 46. Clinical Research Applications of Health Disparities Science in Community Settings

Background

Clinical Research Studies that can be Conducted in Community Settings

Health Services Research

Patient-Oriented Research

Steps to Consider When Conducting Clinical Research in Community Settings

Community Engagement, Collaboration, and Participatory Research

Future Directions

Summary Questions

REFERENCES AND NOTES

Chapter 47. Issues and Challenges for Clinical Research in International Settings

Introduction

Historical Perspectives

Challenges

Proffered Solutions

Conclusion

Summary Questions

REFERENCES

Chapter 48. The Power of an Undiagnosed Diseases Program in a Clinical Research Enterprise

Introduction

Mechanics

Cases

Genetics

Publicity

Future

Insights

Acknowledgments

Summary Questions

REFERENCES

Chapter 49. Human Genome Project, Genomics, and Clinical Research

Overview

Genetic Models

Complex Trait Dissection

Sample Collection and Informed Consent

Approach to Genotyping

Linkage Analysis

Association and Linkage Disequilibrium

Gene Identification

Integration of Genetics into Medical Practice

Summary

Acknowledgments

Summary Questions

REFERENCES

Chapter 50. Harnessing Information Using Genomic Platforms

Introduction

SNP Arrays

Whole Exome Sequencing

Methylation

Summary/Discussion Questions

REFERENCES

APPENDIX 1. Answer Key to Summary Questions

Chapter 1

Chapter 2

Chapter 4

Chapter 5

Chapter 6

Chapter 7

Chapter 8

Chapter 9

Chapter 11

Chapter 12

Chapter 13

Chapter 14

Chapter 15

Chapter 16

Chapter 18

Chapter 19

Chapter 20

Chapter 21

Chapter 23

Chapter 24

Chapter 25

Chapter 26

Chapter 27

Chapter 28

Chapter 29

Chapter 30

Chapter 31

Chapter 32

Chapter 34

Chapter 35

Chapter 37

Chapter 38

Chapter 41

Chapter 42

Chapter 43

Chapter 44

Chapter 45

Chapter 46

Chapter 47

Chapter 48

Chapter 49

Chapter 50

APPENDIX 2. Principles and Practice of Clinical Research, 3rd Edition Acronyms by Chapter

Chapter 1 (Dr. J.I. Gallin)

Chapter 2 (Dr. Grady)

Chapter 3 (Dr. Emanuel)

Chapter 4 (Dr. Colbert)

Chapter 5 (Dr. Wichman)

Chapter 6 (Dr. Rosenfeld)

Chapter 7 (Dr. Zoon)

Chapter 8 (Ms. St. Germain)

Chapter 9 (Dr. Friedman)

Chapter 10 (Dr. Straus)

Chapter 11 (Patricia Kvochak, Esq.)

Chapter 12 (Dr. Nussenblatt)

Chapter 13 (Dr. Kelty)

Chapter 14 (Dr. Speers)

Chapter 15 (Dr. Zarin)

Chapter 16 (Mr. Burklow)

Chapter 17 (Ms. Butler)

Chapter 18 (Dr. Johnson)

Chapter 19 (Dr. Stoney)

Chapter 20 (Dr. Shaw)

Chapter 21 (Dr. Johnson)

Chapter 22 (Dr. Borkowf)

Chapter 23 (Dr. Johnson)

Chapter 24 (Dr. Johnson)

Chapter 25 (Dr. Gerber)

Chapter 26 (Dr. Califf)

Chapter 27 (Dr. Sun)

Chapter 28 (Dr. Chan)

Chapter 29 (Dr. Stoney)

Chapter 30 (Mr. Goldstein)

Chapter 31 (Mr. Goldstein)

Chapter 32 (Dr. Nussenblatt)

Chapter 33 (Ms. Matula)

Chapter 34 (Dr. Cimino)

Chapter 35 (Dr. Pitt)

Chapter 36 (Dr. Bartlett)

Chapter 37 (Ms. Resnik)

Chapter 38 (Dr. E.K. Gallin)

Chapter 39 (Ms. Lee)

Chapter 40 (Dr. Remaley)

Chapter 41 (Dr. Bluemke)

Chapter 42 (Dr. Klein)

Chapter 43 (Dr. Lertora)

Chapter 44 (Dr. Ognibene)

Chapter 45 (Dr. Hastings)

Chapter 46 (Dr. Dankwa-Mullan)

Chapter 47 (Dr. Olopade)

Chapter 48 (Dr. Gahl)

Chapter 49 (Dr. Korf)

Chapter 50 (Dr. Hart)

Index

Quotes and reviews

PRAISE FOR THE FIRST EDITION:
"...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional libraries..."—THE NEW ENGLAND JOURNAL OF MEDICINE
"...it 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

"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition.  Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research…This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals."--Journal of Clinical Research Best Practices, May 2013

 
 
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