Principles and Practice of Clinical Research.

Front Cover -- PRINCIPLES AND PRACTICE OF CLINICAL RESEARCH -- 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 -- SUMMARY QUESTIONS -- References -- 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 -- CONCLUSION -- SUMMARY QUESTIONS -- References -- 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 -- SUMMARY QUESTIONS -- References -- 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 -- SUMMARY QUESTIONS -- 7 - International Regulation of Drugs and Biological Products -- INTRODUCTION -- BACKGROUND -- 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 -- References -- 8 - Clinical Research in International Settings: Opportunities, Challenges, and Recommendations -- INTRODUCTION -- 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 -- CONCLUSION -- SUMMARY QUESTIONS -- References -- 9 - The Role and Importance of Clinical Trial Registries and Results Databases -- INTRODUCTION -- BACKGROUND -- 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 Standards and the Minimal Data Set -- Points to Consider -- 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 -- CONCLUSION -- SUMMARY/DISCUSSION QUESTIONS -- References -- 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 -- SUMMARY -- SUMMARY QUESTIONS -- Acknowledgments -- References -- 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 -- Acknowledgments -- References -- Further Reading -- 12 - Legal Issues in Clinical Research -- INTRODUCTION -- 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.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.