Clinical and Translational Science: Principles of Human Research

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 medicineBrings insights from international leaders into the discipline of clinical and translational scienceAddresses 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

Section I. Fundamental Principles 1. Introduction to Clinical Research 2. Patient-Oriented Research 3. Clinical Trials 4. Introduction to Epidemiology 5. The Patient-Centered Outcomes Research Institute: Current Approach to Funding Clinical Research and Future Directions 6. Health-Care Technology Assessment (HTA) 7. Health Services Research: Translating Discovery and Research Into Practice and Policy

Section II. Approaches 8. Measurement of Biological Materials 9. Imaging Tools in Clinical Research: Focus on Imaging Technologies 10. Imaging Tools in Human Research: Focus on Image-Guided Intervention 11. Nanotechnology in Clinical and Translational Research 12. The Use of Questionnaires and Surveys 13. Information Technology 14. Principles of Biostatistics 15. Good Clinical Practice and Good Laboratory Practice

Section III. Human Genetics 16. Introduction to Human Genetics 17. Epidemiologic and Population Genetic Studies 18. Pharmacogenetics of Drug Metabolism 19. Statistical Techniques for Genetic Analysis

Section IV. Human Pharmacology 20. Introduction to Clinical Pharmacology 21. Adverse Drug Events

Section V. Societal Context of Human Research 22. Translating Science to the Bedside: The Innovation Pipeline 23. Regulatory Environment 24. Ethical Issues in Translational Research and Clinical Investigation 25. Clinical Research in the Public Eye

Section VI. Research in Special Populations 26. Research in Special Populations: Acute Illnesses; Critical Care; and Surgical Patients 27. Research in the Emergency Care Environment 28. Psychiatric Disorders 29. Research in Special Populations: Geriatrics 30. Clinical Research in Neurology 31. Research in Pediatrics 32. Cancer as a Paradigm for Translational and Clinical Biomedical Research 33. Maintaining an Emphasis on Rare Diseases With Research Initiatives and Resources at the National Center for Advancing Translational Sciences

Section VII. Infrastructure 34. Clinical and Translational Science Infrastructure

Section VIII. Education, Training and Career Choices 35. Education, Training and Career Choices: Training Basic, Clinical, and Translational Investigators 36. A Stepwise Approach to a Career in Translational Research 37. Physician Careers in the Pharmaceutical Industry

Section IX. Research in Academia 38. Industry-Sponsored Clinical Research in Academia 39. Governmental Support of Research 40. The Role of Nonprofit, Nongovernmental Funding in Support of Biomedical Research 41. Modern Drug Discovery and Development 42. Pharmaceutical and Biotechnology Sector Support of Research

Section X. Prospectus 43. The Future of Clinical Research