Description
Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health.This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science.- Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine- Brings insights from international leaders into the discipline of clinical and translational science- Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs
Table of Contents
Section I. Fundamental Principles1. Introduction to Clinical Research2. Patient-Oriented Research3. Clinical Trials4. Introduction to Epidemiology5. The Patient-Centered Outcomes Research Institute: Current Approach to Funding Clinical Research and Future Directions6. Health-Care Technology Assessment (HTA)7. Health Services Research: Translating Discovery and Research Into Practice and PolicySection II. Approaches8. Measurement of Biological Materials9. Imaging Tools in Clinical Research: Focus on Imaging Technologies10. Imaging Tools in Human Research: Focus on Image-Guided Intervention11. Nanotechnology in Clinical and Translational Research12. The Use of Questionnaires and Surveys13. Information Technology14. Principles of Biostatistics15. Good Clinical Practice and Good Laboratory PracticeSection III. Human Genetics16. Introduction to Human Genetics17. Epidemiologic and Population Genetic Studies18. Pharmacogenetics of Drug Metabolism19. Statistical Techniques for Genetic AnalysisSection IV. Human Pharmacology20. Introduction to Clinical Pharmacology21. Adverse Drug EventsSection V. Societal Context of Human Research22. Translating Science to the Bedside: The Innovation Pipeline23. Regulatory Environment24. Ethical Issues in Translational Research and Clinical Investigation25. Clinical Research in the Public EyeSection VI. Research in Special Populations26. Research in Special Populations: Acute Illnesses; Critical Care; and Surgical Patients27. Research in the Emergency Care Environment28. Psychiatric Disorders29. Research in Special Populations: Geriatrics30. Clinical Research in Neurology31. Research in Pediatrics32. Cancer as a Paradigm for Translational and Clinical Biomedical Research33. Maintaining an Emphasis on Rare Diseases With Research Initiatives and Resources at the National Center for Advancing Translational SciencesSection VII. Infrastructure34. Clinical and Translational Science InfrastructureSection VIII. Education, Training and Career Choices35. Education, Training and Career Choices: Training Basic, Clinical, and Translational Investigators36. A Stepwise Approach to a Career in Translational Research37. Physician Careers in the Pharmaceutical IndustrySection IX. Research in Academia38. Industry-Sponsored Clinical Research in Academia39. Governmental Support of Research40. The Role of Nonprofit, Nongovernmental Funding in Support of Biomedical Research41. Modern Drug Discovery and Development42. Pharmaceutical and Biotechnology Sector Support of ResearchSection X. Prospectus43. The Future of Clinical Research
