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.
- Features input from experts in the field dedicated to translating scientific research from bench to bedside and back
- Provides expanded coverage of global clinical research
- Contains hands-on, practical suggestions, illustrations, and examples throughout
- Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting
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Table of Contents
1. A Historical Perspective on Clinical Research
Part I - Ethical, Regulatory and Legal Issues 2. Ethical Principles in Clinical Research 3. Integrity in Research: Principles for the Conduct of Research 4. Institutional Review Boards 5. The Regulation of Drugs and Biological Products by the Food and Drug Administration 6. International Regulation of Drugs and Biological Products 7. Data Management in Clinical Trials 8. Data and Safety Monitoring 9. Unanticipated Risk in Clinical Research 10. Legal Issues 11. Inclusion of Women and Minorities as Subjects in Clinical Research 12. Accreditation of Human Research Protection Programs 13. The Role and Importance of Clinical Trials Registries 14. The Clinical Researcher and the Media 15. Clinical Research: A Patient Perspective
Part II - Biostatistics and Epidemiology 16. Design of Observational Studies 17. Design of Interventional Studies and Trials 18. Issues in Randomization 19. Hypothesis Testing 20. Power and Sample Size Calculations 21. An Introduction to Survival Analysis 22. Intermediate Topics in Biostatistics 23. Measures of Function and Health-Related Quality of Life 24. Large Clinical Trials and Registries: Clinical Research Institutes 25. Meta-analysis of Clinical Trials 26. Using Large Datasets for Population-based Health Research 27. Development and Conduct of Studies
Part III - Technology Transfer, Protocol Development, and Sources of Funding Support for Research 28. Overview of Technology Development and Technology Transfer 29. Writing a Protocol 30. Evaluating a Protocol Budget 31. Clinical Research Data: Characteristics, Representation, Storage and Retrieval 32. Management of Patient Samples and Specimens 33. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process 34. Clinical Research from the Industry Perspective 35. Philanthropy's Role in Advancing Biomedical Research
Part IV - Clinical Research Infrastructure 36. Managing Clinical Risk and Measuring Participants’ Perceptions of the Clinical Research Process 37. Clinical Pharmacology and its Role in Pharmaceutical Development 38. Career Paths in Clinical Research 39. Clinical Research Nursing: A New Domain of Practice 40. Issues and Challenges for Clinical Research in International Settings 41. The Role of Comparative Effectiveness Research 42. The Importance and Use of Electronic Health Records in Clinical Research 43. Informational Resources for the Clinical Researcher