Principles and practice of clinical research

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 transla...

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Bibliographic Details
Main Authors Gallin, John I., Ognibene, Frederick P.
Format eBook Book
LanguageEnglish
Published Amsterdam ; Boston Academic Press 2007
Elsevier Science & Technology
Edition2
Subjects
Clinical medicine
Clinical medicine > Research
Research > methods
Online AccessGet full text

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Table of Contents:
  • Front cover -- Principles and Practice of Clinical Research -- Copyright page -- Table of contents -- 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 -- Acknowledgment -- 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: Individual and Institutional Responsibility -- 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 -- Acknowledgment -- References -- Chapter 5: Institutional Review Boards -- 1. HISTORICAL, ETHICAL, AND REGULATORY FOUNDATIONS OF CURRENT REQUIREMENTS FOR RESEARCH INVOLVING HUMAN SUBJECTS -- 2. INSTITUTIONAL REVIEW BOARDS
  • 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 -- Further Reading -- 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: Randomization, Hypothesis Testing, and Sample Size Estimation -- 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
  • 4. AGREEMENTS NOT TO DISCLOSE: TRADE SECRETS AND THE CONFIDENTIAL DISCLOSURE AGREEMENT
  • 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 -- References -- 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 -- References -- 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
  • 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 -- Acknowledgments -- References -- Chapter 9: The Regulation of Drugs and Biological Products by the Food and Drug Administration -- 1. INTRODUCTION -- 2. BACKGROUND -- 3. MISSION, ORGANIZATION, AND TERMINOLOGY -- 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
  • References and Notes -- Further Reading -- Appendix: NIH Advance Directive for Health Care and Medical Research Participation -- 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 -- 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 -- Acknowledgments -- References and Notes -- Chapter 13: Clinical Research: A Patient Perspective -- 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