Principles and Practice of Clinical Research
Regular price
50.500 KD
inc. VAT
Couldn't load pickup availability
Table of contents
- Contentsv
- Contributorsxi
- Prefacexiii
- Acknowledgmentsxv
- Chapter 1. A Historical Perspective on Clinical Research1
- The Earliest Clinical Research1
- The Greek and Roman Influence1
- Middle Ages and Renaissance2
- Seventeenth Century3
- Eighteenth Century4
- Nineteenth Century6
- Twentieth Century and Beyond9
- PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES13
- Chapter 2. Ethical Principles in Clinical Research15
- Distinguishing Clinical Research from Clinical Practice15
- What Does Ethics Have to Do with Clinical Research?15
- History of Ethical Attention to Clinical Research16
- Ethical Principles and Guidelines for the Protection of Human Subjects of Research: the Belmont Prin19
- Special Issues in the Conduct of Randomized Clinical Trials23
- Summary25
- Chapter 3. Researching a Bioethical Question27
- Types of Bioethical Issues27
- Types of Bioethical Research Methodologies27
- Examples of Important Bioethical Research28
- Special Considerations in Bioethical Research34
- Chapter 4. Integrity in Research: Individual and Institutional Responsibility39
- Recent History of the Scientific Misconduct Issue39
- Responses of Government40
- Responses of the Scientific Community41
- Guidelines for the Conduct of Research42
- Definition of Scientific Misconduct43
- Authorship44
- Conflicts of Interest44
- Conclusions45
- Chapter 5. Institutional Review Boards51
- Historical, Ethical, and Regulatory Foundations for Current Requirements for Research Involving Huma51
- Institutional Review Boards54
- Clinical Researchers and IRBs60
- The Current IRB System Under Evaluation60
- Conclusion61
- Chapter 6. Data and Safety Monitoring Boards63
- Description of Data and Safety Monitoring Board63
- Data and Safety Monitoring Board Functions64
- Data and Safety Monitoring Board Decision Making65
- Examples65
- Conclusions67
- Chapter 7. Data and Data Management Clinical Trials69
- Definitions69
- Roles and Responsibilities70
- Administrative Aspects72
- Research Records77
- Data Standardization Coding Systems78
- Quality Assurance79
- Audits79
- Audit Preparation81
- Data Analysis83
- Security83
- Archiving84
- Summary84
- Conclusion84
- Chapter 8. Unanticipated Risk in Clinical Research105
- The Reasons106
- The Drug107
- The Target108
- The Trials108
- Cassandra Revealed110
- Extended Studies110
- FIAU Toxicity111
- Reassessing the Preclinical Studies112
- Research Oversight113
- The Investigations Begin113
- Scientific Misconduct114
- The FDA115
- The NIH115
- The Institute of Medicine116
- The Media116
- The Congress117
- The Law118
- Epilogue118
- Chapter 9. The Regulation of Drugs and Biological Products by the Food and Drug Administration123
- Background123
- Mission, Organization, and Terminology124
- Drug and Biologic Life Cycle126
- Summary132
- Appendix132
- Chapter 10. Legal Issues133
- Legal Issues Related to Informed Consent for Clinical and Research Care133
- Advance Directives/Substitute Consent134
- Children in Research136
- Medical/Research Records137
- Legal Liability138
- Conflict of Interest139
- Authorship/Rights in Data140
- Appendix: NIH Advance Directive for Health Care and Medical Research Participation141
- Chapter 11. NIH Policy on the Inclusion of Women and Minorities as Subjects of Clinical Research145
- NIH Policy146
- Focus on Scientific Considerations147
- Role of the NIH Office of Research on Women's Health147
- Role of Peer Review148
- Role of the Institutional Review Board149
- Role of Volunteers and Their Communities150
- Reaction of the Scientific Research Community151
- Demographic Data on Subject Enrollment152
- Identifying Differences between Women and Men154
- Women of Childbearing Potential and Pregnant Women155
- Future Questions156
- Conclusions157
- PART II: BIOSTATISTICS AND EPIDEMIOLOGY161
- Chapter 12. An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size163
- Introduction163
- Issues in Randomization164
- Overview of Hypothesis Testing170
- Sample Size and Power179
- Chapter 13. Design and Conduct of Observational Studies and Clinical Trials187
- Types of Epidemiologic Study Designs187
- Case Reports and Case Series187
- Prevalence Surveys or Cross-Sectional Studies188
- Case-Control Studies190
- Prospective or Longitudinal Cohort Studies193
- Causal Inference in Observational Studies195
- Clinical Trials196
- Conduct of Epidemiologic Studies: The Study Protocol199
- Chapter 14. Small Clinical Trials207
- Where We Are In the Short History of Controlled Clinical Trials207
- Explanatory vs. Pragmatic Orientation in Clinical Trials: Implications for Study Design208
- Issues in Small Clinical Trials that Examine Both Disease Mechanism and Treatment Efficacy209
- Placebo Responses in Clinical Trials217
- Conclusion222
- Chapter 15. Large Clinical Trials: Clinical Research Institutes225
- History225
- Phases of Evaluation of Therapies225
- Critical General Concepts226
- Expressing Clinical Trial Results227
- Concepts Underlying Trial Design229
- Legal and Ethical Issues233
- Hypothesis Formulation236
- Publication Bias238
- Statistical Considerations238
- Meta-Analysis and Systematic Overviews240
- Understanding Covariates and Subgroups241
- Therapeutic Truisms241
- Study Organization242
- Integration into Practice246
- Controversies and Personal Perspective246
- The Future248
- Chapter 16. Using Secondary Data in Statistical Analysis251
- Techniques of Meta-Analysis251
- Meta-Analysis of Clinical Trials of Anti-Inflammatory Agents in Sepsis253
- Conclusions254
- Chapter 17. An Introduction to Survival Analysis259
- Four Motivating Examples259
- Features of Survival Data260
- Survival Function260
- Comparing Two Survival Functions261
- Stratified Logrank Test264
- Proportional Hazards Model265
- Chapter 18. Measures of Function and Health-Related Quality of Life267
- Background About Quality of Life Indicators267
- Definition of Quality of Life267
- Applications for Quality of Life Measures268
- Structure of Quality of Life Measures269
- Criteria for Selection of Quality of Life Measures270
- Specific Quality of Life Instruments270
- Other Instruments to Consider271
- Importance of Quality of Life Measures for Health Care271
- Chapter 19. Economic Analysis and Clinical Research275
- Outline of the Chapter275
- The Evolving Field of Economics and Health276
- Economic Cost and Health277
- Types of Economic Analysis279
- Comparing Costs Across Time and Place288
- The Use of Models in Economic Studies292
- Economic Analysis and Clinical Trials294
- PART III: TECHNOLGY TRANSFER, PROTOCOL DEVELOPMENT, AND FUNDING305
- Chapter 20. Overview of Technology Development307
- Scenario: Disasters Waiting to Happen308
- The First and Biggest Mistake: Signing the Agreements309
- Agreements Not To Disclose: Trade-Secrets and the "CDA"311
- Agreements to Transfer Materials313
- Collaboration and Inventions: The "CRADA"319
- Proprietary Materials: The Materials-CRADAŽ323
- Trademarks and Copyrights for the Government Scientist324
- Conclusion327
- Chapter 21. Technology Transfer329
- What is Technology Transfer?329
- What is a Patent?330
- What is an Invention?330
- Who is an Inventor?331
- How to/Not to Disclose an Invention333
- Why Obtain a Patent?338
- When to Seek a Patent338
- Processing Employee Invention Reports at the NIH339
- Where to Obtain a Patent?339
- Statutory and Administrative Basis for Patents340
- Patent Attorneys and Agents340
- Preparing the Patent Application340
- Actions By the U.S. Patent Examiner341
- Appeals from Adverse Examiner's Decisions343
- U.S. Patent Interferences344
- International Treaties and Foreign Patents344
- Procedures Under The Patent Cooperation Treaty345
- The European Patent Convention346
- The European Patent Office347
- National Patent Offices347
- Patent Prosecution Fees347
- The Licensing Process348
- Rights in Government Funded Extramural Inventions348
- Inventions Made in Federal Laboratories348
- Joint Inventions With Non-PHS Co-inventors348
- Types of Licenses Available at the NIH353
- Appendix 1: Research Plan359
- Appendix 2: Exceptions or Modifications to This Crada359
- Summary of Key Points to Remember359
- Chapter 22. Telemedicine Systems361
- Background361
- Common Architectures for Telemedicine365
- Early NIH Telemedicine Activities367
- Development of a Comprehensive NIH Telemedicine Infrastructure (1993–Present)377
- The National Effort to Advance Telemedicine Systems381
- Conclusions384
- Chapter 23. Animal Models of Human Disease387
- What Does the Clinician Need to Know About Animal Models?387
- The Choice of an Animal Model388
- The Amazing Development of Mouse Molecular Genetics389
- Chapter 24. Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine401
- Public Use of Complementary and Alternative Medicine401
- Conventional Physician Use of CAM402
- The Risks of CAM402
- Potential Benefits of CAM402
- Reasons for CAM Use403
- Research Evaluation Principles in Medicine403
- Goals and Their Design Elements in CAM Clinical Trials408
- Special Issues in Clinical Research on CAM409
- Evaluation of Specific CAM Practices415
- Developing Research Strategies for CAM420
- Chapter 25. Preparing Scientific Images for Publication and Display427
- Determining Your Needs427
- Image Resolution428
- Bitmapped versus Vector Images430
- Typography Basics431
- WYSIWYG432
- Image Acquisition and Editing433
- Image File Formats433
- Word Processing434
- Drawing Software435
- PostScript Illustration Programs435
- Desktop Publishing Software436
- Presentation Software436
- HTML Software436
- Conclusions437
- Chapter 26. Writing a Clinical Protocol: The Mechanics439
- The Very First Steps439
- Molecular Correlative Studies441
- Framing the Question Being Asked442
- Converting Problems into Assets443
- Allocation of Time and Effort444
- Elements of the Protocol Document445
- Terms to be Familiar With447
- Chapter 27. Getting the Funding You Need to Support Your Research: Successfully Navigating the NIH P449
- Overview of the NIH449
- The NIH Peer Review Process for Grants454
- Hints For Preparing Better Grant Applications462
- NIH Award Mechanisms For Support of Clinical Researchers at Various Stages in Their Careers471
- How to Stay Informed About the NIH Peer Review System474
- Appendix475
- Index477
- Table 3 Quality of Life Measures491
- Table 4 Properties of QoL Measures That Establish a Firm Conceptual Basis (Ventegodt, Hilden, Zachau492
- Table 5 Domains Assessed in QoL Measures493
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research.
This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research.
Key Features
* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research
This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research.
Key Features
* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research