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Principles and Practice of Clinical Research / edited by John I. Gallin, Frederick P. Ognibene, Laura Lee Johnson.
- Format:
- Book
- Language:
- English
- Subjects (All):
- Clinical Medicine--Research.
- Medical Subjects:
- Clinical Medicine--Research.
- Physical Description:
- 1 online resource (807 pages) : illustrations, photographs
- Edition:
- Fourth edition.
- Place of Publication:
- London, England : Academic Press, 2018.
- Summary:
- Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research.
- Contents:
- Front Cover
- PRINCIPLES AND PRACTICE OF CLINICAL RESEARCH
- Copyright
- Contents
- List of Contributors
- Acknowledgments
- Preface
- 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
- SUMMARY QUESTIONS
- References
- I - ETHICAL, REGULATORY AND LEGAL ISSUES
- 2 - Ethical Principles in Clinical Research
- DISTINGUISHING CLINICAL RESEARCH FROM CLINICAL PRACTICE
- ETHICS AND CLINICAL RESEARCH
- HISTORY OF ETHICAL ATTENTION TO CLINICAL RESEARCH
- Benefit to the Individual
- Benefit to Society
- Protection of Research Subjects
- Research as a Benefit
- Community Involvement in Research
- CODES OF RESEARCH ETHICS AND REGULATIONS
- RESEARCH ON BIOETHICAL QUESTIONS
- ETHICAL FRAMEWORK FOR CLINICAL RESEARCH
- Value and Validity
- Fair Subject Selection
- Favorable Risk/Benefit Ratio
- Independent Review
- Informed Consent
- Respect for Enrolled Subjects
- ETHICAL CONSIDERATIONS IN RANDOMIZED CONTROLLED TRIALS
- CONCLUSION
- 3 - Integrity in Research: Principles for the Conduct of Research
- GUIDELINES AND PRINCIPLES FOR THE CONDUCT OF RESEARCH
- SCIENTIFIC INTEGRITY AND RESEARCH MISCONDUCT
- RESPONSIBILITIES OF RESEARCH SUPERVISORS AND TRAINEES
- DATA MANAGEMENT, ARCHIVING, AND SHARING
- Data Management
- Archiving
- Data Sharing
- RESEARCH INVOLVING HUMAN AND ANIMAL SUBJECTS
- COLLABORATIVE AND TEAM SCIENCE
- CONFLICT OF INTEREST AND COMMITMENT
- PEER REVIEW
- PUBLICATION PRACTICES, RESPONSIBLE AUTHORSHIP, AND RESULTS REPRODUCIBILITY
- Publication Practices
- Authorship
- Reproducibility
- STUDY QUESTIONS
- Acknowledgments.
- References
- Further Reading
- 4 - Institutional Review Boards
- HISTORICAL, ETHICAL, AND REGULATORY FOUNDATIONS OF CURRENT REQUIREMENTS FOR RESEARCH INVOLVING HUMAN SUBJECTS
- Historical Foundations
- Ethical Foundations
- Regulatory Foundations
- INSTITUTIONAL REVIEW BOARDS
- Key Concepts and Definitions From the Common Rule
- Research
- Exempt Research Activities
- Minimal Risk and Expedited Review Procedures
- Institutional Review Board's Review of Research
- Institutional Review Board Membership
- Criteria for Institutional Review Board Approval of Research
- Continuing Review of Research
- CLINICAL RESEARCHERS AND INSTITUTIONAL REVIEW BOARDS
- EVALUATION AND EVOLUTION OF THE CURRENT SYSTEM OF RESEARCH OVERSIGHT AND INSTITUTIONAL REVIEW BOARDS
- Proposed Changes to Current Oversight of Research With Human Subjects
- Critique and Proposed Changes to Institutional Review Board Operations
- 5 - Accreditation of Human Research Protection Programs
- A BRIEF HISTORY
- PRINCIPLES OF ACCREDITATION
- What AAHRPP Expects From Organizations
- What Organizations Can Expect From AAHRPP
- HUMAN RESEARCH PROTECTION PROGRAMS: THE SHIFT TO SHARED RESPONSIBILITY
- THE ACCREDITATION STANDARDS
- Domain I: Organization
- Domain II: Institutional Review Board or Ethics Committee
- Domain III: Researcher and Research Staff
- STEPS TO ACCREDITATION
- VALUE OF ACCREDITATION
- 6 - The Regulation of Drugs and Biological Products by the Food and Drug Administration
- BACKGROUND
- MISSION AND TERMINOLOGY
- DRUG AND BIOLOGICAL PRODUCT LIFE CYCLE
- Discovery/Nonclinical Investigation
- Clinical Trials
- Responsibilities and Documentation
- Sponsors
- Investigators
- Clinical Protocol
- Institutional Review Board
- Food and Drug Administration.
- Investigator Brochure
- Investigational New Drug Safety Reports
- Marketing Approval/Licensure
- Pre-New Drug Application/Biologics License Application Submission
- Application
- Food and Drug Administration Review
- Postapproval
- COMPLIANCE
- SUMMARY
- 7 - International Regulation of Drugs and Biological Products
- INTRODUCTION
- Early Operations and Achievements of International Conference on Harmonisation
- Recent Evolution and Reforms
- Membership in the New International Council on Harmonisation
- Organization of the New International Council on Harmonisation
- Financing the New International Council on Harmonisation
- OVERVIEW OF THE INTERNATIONAL COUNCIL ON HARMONISATION TECHNICAL HARMONIZATION PROCESS
- Nomination and Selection of Topics for Harmonization
- International Council on Harmonisation Five-Step Harmonization Procedure
- INTERNATIONAL COUNCIL ON HARMONISATION GUIDELINES MOST RELEVANT TO CLINICAL RESEARCH
- FUTURE WORK IN REGULATORY HARMONIZATION
- 8 - Clinical Research in International Settings: Opportunities, Challenges, and Recommendations
- CHALLENGES
- Inadequate Human Resources
- Deficient Research Infrastructures
- Subpar Health-Care Systems
- Information Gaps
- Political Instability, Civil Disorders, and Natural Disasters
- Economic and Seasonal Migration
- Physical Barriers
- Study Participant Characteristics
- Ethical Issues
- RECOMMENDATIONS
- Understand the Local Setting
- Train, Mentor, and Closely Supervise
- Develop and Enhance Local Institutional Review Board Capacity
- Develop Office for Sponsored Research/Office of Clinical Research
- Prepare Data Safety and Monitoring Plan for Adverse Events
- Provide Ancillary Care
- Use Technology for Effective Communication
- Have Long-Term Plans.
- Integrate With Existing Infrastructure
- 9 - The Role and Importance of Clinical Trial Registries and Results Databases
- Definitions
- Rationale for Clinical Trial Registration and Results Reporting
- History of ClinicalTrials.gov
- CURRENT POLICIES
- Policies Affecting Clinical Trials in the United States
- International Landscape
- REGISTERING CLINICAL TRIALS AT CLINICALTRIALS.GOV
- Data Standards and the Minimal Data Set
- Points to Consider
- Interventional Versus Observational Studies
- What Is a Single Clinical Trial?
- Importance of the Protocol
- Keeping Information Up-to-Date
- REPORTING RESULTS TO CLINICALTRIALS.GOV
- Data Preparation
- Review Criteria
- Relation of Results Reporting to Publication
- Key Scientific Principles and Best Practices for Reporting
- Issues in Reporting Outcome Measures
- Issues Related to Analysis Population
- USING CLINICALTRIALS.GOV DATA
- Intended Audience
- Search Tips for ClinicalTrials.gov
- Points to Consider When Using ClinicalTrials.gov to Study the Overall Clinical Research Enterprise
- LOOKING FORWARD
- SUMMARY/DISCUSSION QUESTIONS
- 10 - Data and Safety Monitoring
- WHY MONITOR?
- WHO MONITORS?
- Data and Safety Monitoring Board
- History of Data and Safety Monitoring Boards
- When Is a Data and Safety Monitoring Board Needed?
- WHAT TO MONITOR?
- Monitoring Participant Safety
- Monitoring Trial Conduct
- Participant Flow
- Participants' Baseline Characteristics
- Randomization Outcome
- Regulatory Compliance
- Trial Performance
- Protocol Compliance by Research Staff
- Recruitment
- Participants' Treatment Adherence (Treatment Exposure).
- Data Completeness (Availability of Primary and Other Key Endpoints)
- Attendance at Follow-Up Visits (Retention)
- Data Quality
- Flags and Triggers
- Interim Analyses
- Sample Size Recalculation
- Sample Size Recalculation Based Only on Nuisance Parameters
- Sample Size Recalculation Based on Nuisance Parameters and Observed Treatment Effect
- Interim Analyses for Efficacy, Futility, and/or Harm
- Sequential Designs (Also Known as Group Sequential Tests or Repeated Significance Tests)
- Stochastic Curtailment Tests
- WHEN AND HOW OFTEN TO MONITOR?
- SPECIAL TOPICS
- General Structure of Data and Safety Monitoring Board Meetings
- Masking of the Data and Safety Monitoring Board
- 11 - Unanticipated Risk in Clinical Research∗
- THE REASONS
- THE DRUG
- THE TARGET
- THE TRIALS
- CASSANDRA REVEALED
- EXTENDED STUDIES
- FIALURIDINE TOXICITY
- REASSESSING THE PRECLINICAL STUDIES
- RESEARCH OVERSIGHT
- THE INVESTIGATIONS BEGIN
- SCIENTIFIC MISCONDUCT
- THE FOOD AND DRUG ADMINISTRATION
- THE NATIONAL INSTITUTES OF HEALTH
- THE INSTITUTE OF MEDICINE
- THE MEDIA
- THE CONGRESS
- THE LAW
- EPILOGUE
- Drug Development
- Is Preclinical Testing of New Drugs a Reliable Predictor of Toxicity?
- Are Patients in Drug Trials Monitored Carefully and Objectively Enough?
- Clinical Research Training
- Personal Perspectives
- 12 - Legal Issues in Clinical Research
- PROTECTING INDIVIDUAL PARTICIPANT INTERESTS
- Independent Review and Monitoring
- Informed Consent, Surrogate Consent, Advance Directives, and Children's Assent
- The Content of Informed Consent Processes
- Who Can Provide Informed Consent-Adults
- Who Can Provide Informed Consent-Children.
- SPECIAL PROTECTIONS FOR FETAL TISSUE, HUMAN EMBRYOS, AND HUMAN EMBRYONIC STEM CELLS.
- Notes:
- Includes bibliographical references at the end of each chapters and index.
- Description based on online resource; title from PDF title page (EBC, viewed November 28, 2017).
- Description based on publisher supplied metadata and other sources.
- ISBN:
- 9780128499047
- 0128499044
- 9780128499054
- 0128499052
- OCLC:
- 1009334589
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