Principles and Practice of Clinical Research

ISBN-13: 9780128499054 / Angielski / Twarda / 2017 / 824 str.

John I. Gallin; Frederick P. Ognibene; Laura Lee Johnson

Opis

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 informational 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 human 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 four new chapters devoted to international regulations of drugs and biological products, the importance and use of electronic health records in clinical research, informational resources for the clinical researcher, and advances in access and utility of large data networks and research

Spis treści

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

O autorze

John I. Gallin, MD, serves as the Chief Scientific Officer (CSO) and the Scientific Director (SD) of the NIH Clinical Center. He is also NIH's Associate Director for Clinical Research in the Office of Clinical Research, Office of the Director. Dr. Gallin was the Director of the NIH Clinical Center from 1994-2017 and was the Scientific Director for intramural research activities at the National Institute of Allergy and Infectious Diseases (NIAID) from 1985 to 1994. He was also the founding Chief of the NIAID Laboratory of Host Defenses and continues as Chief of the Clinical Pathophysiology Section which has become part of a new Laboratory of Clinical Immunology and Microbiology Laura Lee Johnson, Ph.D. is the patient focused drug development liaison and the division director for the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, implementation, and analysis of research studies of all sizes and in measurement tool and endpoint development. Prior to working at the FDA she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.