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. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications.
In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research.
1. Chapter 26. An Introduction to Survival Analysis - p. 373 2. Chapter 27. Intermediate Topics in Biostatistics - p. 383 3. Chapter 28. Large Clinical Trials and Registries—Clinical Research Institutes - p. 411 4. Introduction - p. 412 5. History - p. 412 6. Phases of Evaluation of Therapies - p. 413 7. Critical General Concepts - p. 414 8. Expressing Clinical Trial Results - p. 415 9. Concepts Underlying Trial Design - p. 417 10. General Design Considerations - p. 420 11. Legal and Ethical Issues - p. 422 12. Hypothesis Formulation - p. 427 13. Publication Bias - p. 427 14. Statistical Considerations - p. 428 15. Meta-analysis and Systematic Reviews - p. 430 16. Understanding Covariates and Subgroups - p. 431 17. Therapeutic Truisms - p. 432 18. Operational Organization for Large-Scale Clinical Research - p. 433 19. Integration Into Practice - p. 437 20. Controversies and Personal Perspective - p. 437 21. The Future - p. 439 22. Summary Questions - p. 440 23. Part III. Technology Transfer, Data Management, and Sources of Funding Support for Research - p. 444 24. Chapter 29. Intellectual Property and Technology Transfer - p. 447 25. Introduction - p. 448 26. Part One: Intellectual Property Generally - p. 448 27. Part Two: Patents and Technology Transfer - p. 487 28. Part Three: Technology Transfer Agreements - p. 503 29. Conclusion - p. 518 30. Brief Glossary of Critical Terms in Patenting - p. 519 31. Review Questions - p. 519 32. Chapter 30. Data Management in Clinical Trials - p. 531 33. Chapter 31. Clinical Research Data: Characteristics, Representation, Storage, and Retrieval - p. 547 34. Chapter 32. Management of Patient Samples - p. 559 35. Chapter 33. Evaluating a Protocol Budget - p. 571 36. Chapter 34. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process - p. 589 37. Chapter 35. Philanthropy's Role in Advancing Biomedical Research - p. 611 38. Part IV. Clinical Research Infrastructure - p. 630 39. Chapter 36. Identifying, Understanding, and Managing Patient Safety and Clinical Risks in the Clinical Research Environment - p. 633 40. Chapter 37. Clinical Pharmacology and Its Role in Pharmaceutical Development - p. 645 41. Chapter 38. Career Paths in Clinical Research - p. 661 42. Chapter 39. Clinical Research Nursing: A New Domain of Practice - p. 671 43. Chapter 40. The Importance and Use of Electronic Health Records in Clinical Research - p. 687 44. Chapter 41. The Clinical Researcher and the Media - p. 703 45. Chapter 42. Information Resources for the Clinical Researcher - p. 713 46. Appendix 1. Answer Key to Summary Questions - p. 753 47. Appendix 2. Acronyms - p. 761 48. Index - p. 775
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. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications.
In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research.
1. Chapter 26. An Introduction to Survival Analysis - p. 373 2. Chapter 27. Intermediate Topics in Biostatistics - p. 383 3. Chapter 28. Large Clinical Trials and Registries—Clinical Research Institutes - p. 411 4. Introduction - p. 412 5. History - p. 412 6. Phases of Evaluation of Therapies - p. 413 7. Critical General Concepts - p. 414 8. Expressing Clinical Trial Results - p. 415 9. Concepts Underlying Trial Design - p. 417 10. General Design Considerations - p. 420 11. Legal and Ethical Issues - p. 422 12. Hypothesis Formulation - p. 427 13. Publication Bias - p. 427 14. Statistical Considerations - p. 428 15. Meta-analysis and Systematic Reviews - p. 430 16. Understanding Covariates and Subgroups - p. 431 17. Therapeutic Truisms - p. 432 18. Operational Organization for Large-Scale Clinical Research - p. 433 19. Integration Into Practice - p. 437 20. Controversies and Personal Perspective - p. 437 21. The Future - p. 439 22. Summary Questions - p. 440 23. Part III. Technology Transfer, Data Management, and Sources of Funding Support for Research - p. 444 24. Chapter 29. Intellectual Property and Technology Transfer - p. 447 25. Introduction - p. 448 26. Part One: Intellectual Property Generally - p. 448 27. Part Two: Patents and Technology Transfer - p. 487 28. Part Three: Technology Transfer Agreements - p. 503 29. Conclusion - p. 518 30. Brief Glossary of Critical Terms in Patenting - p. 519 31. Review Questions - p. 519 32. Chapter 30. Data Management in Clinical Trials - p. 531 33. Chapter 31. Clinical Research Data: Characteristics, Representation, Storage, and Retrieval - p. 547 34. Chapter 32. Management of Patient Samples - p. 559 35. Chapter 33. Evaluating a Protocol Budget - p. 571 36. Chapter 34. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process - p. 589 37. Chapter 35. Philanthropy's Role in Advancing Biomedical Research - p. 611 38. Part IV. Clinical Research Infrastructure - p. 630 39. Chapter 36. Identifying, Understanding, and Managing Patient Safety and Clinical Risks in the Clinical Research Environment - p. 633 40. Chapter 37. Clinical Pharmacology and Its Role in Pharmaceutical Development - p. 645 41. Chapter 38. Career Paths in Clinical Research - p. 661 42. Chapter 39. Clinical Research Nursing: A New Domain of Practice - p. 671 43. Chapter 40. The Importance and Use of Electronic Health Records in Clinical Research - p. 687 44. Chapter 41. The Clinical Researcher and the Media - p. 703 45. Chapter 42. Information Resources for the Clinical Researcher - p. 713 46. Appendix 1. Answer Key to Summary Questions - p. 753 47. Appendix 2. Acronyms - p. 761 48. Index - p. 775
