Translational Pulmonology
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2025
ISBN13: 9780323903912
Rubricering
Onderdeel van serie
Handbook for Designing and Conducting Clinical and Translational Research
Levertijd ongeveer 8 werkdagen
Samenvatting
Translational research is essential to the advancement of medicine. Translational Pulmonology is an instructional guide to translational medical research serves as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in pulmonary diseases, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research within the field.
Specificaties
Inhoudsopgave
Introduction <br>1. Introduction<br>2. Translational process<br>3. Scientific Method<br><br>Pre-Clinical <br>4. Overview of Preclinical Research<br>5. What Problem are You Solving?<br>6. Types of Interventions<br>7. Drug Discovery<br>8. Drug Testing<br>9. Device Discovery and Prototyping<br>10. Device Testing<br>11. Diagnostic Discovery<br>12. Other Product Types<br>13. Procedural Technique Development<br>14. Behavioral Intervention<br>15. Artificial Intelligence<br><br>Clinical: Fundamentals <br>16. Introduction to Clinical Research: What is it? Why is it Needed?<br>17. The Question: Types of Research Questions and how to Development Them<br>18. Study Population: Who and Why Them?<br>19. Outcome Measurements: What Data is Being Collected and Why?<br>20. Optimizing the Question: Balancing Significance and Feasibility<br><br>Statistical Principles <br>21. Common Issues in Analysis<br>22. Basic Statistical Principles<br>23. Hypotheses and Error Types<br>24. Power<br>25. Regression<br>26. Continuous Variable Analyses<br>27. Categorical Variable Analyses: Chi-square, Fisher Exact, Mantel Hanzel<br>28. Correlation<br>29. Biases<br>30. Basic Science Statistics<br>31. Sample Size<br>32. Statistical Software<br><br>Clinical: Study Types <br>33. Design Principles: Hierarchy of Study Types<br>34. Case Series: Design, Measures, Classic Example<br>35. Case-Control Study: Design, Measures, Classic Example<br>36. Cohort Study: Design, Measures, Classic Example<br>37. Cross-section Study: Design, Measures, Classic Example<br>38. Longitudinal Study: Design Measures, Classic Example<br>39. Meta-analysis: Design, Measures, Classic Example<br>40. Cost-effectiveness Study: Design, Measures, Classic Example<br>41. Diagnostic Test Evaluation: Design, Measures, Classic Example<br>42. Reliability Study: Design, Measures, Classic Example<br>43. Database Studies: Design, Measures, Classic Example<br>44. Surveys and Questionnaires: Design, Measures, Classic Example<br>45. Qualitative Methods and Mixed Methods<br><br>Clinical Trials <br>46. Randomized Control: Design, Measures, Classic Example<br>47. Historical Control: Design, Measures, Classic Example<br>48. Cross-Over: Design, Measures, Classic Example<br>49. Withdrawal Studies: Design, Measures, Classic Example<br>50. Factorial Design: Design, Measures, Classic Example<br>51. Group Allocation: Design, Measures, Classic Example<br>52. Hybrid Design: Design, Measures, Classic Example<br>53. Large, Pragmatic: Design, Measures, Classic Example<br>54. Equivalence and Noninferiority: Design, Measures, Classic Example<br>55. Adaptive: Design, Measures, Classic Example<br>56. Phase 0 Trials: Window of Opportunity<br>57. Registries<br>58. Phases of Clinical Trials<br>59. IDEAL Framework<br><br>Clinical: Preparation <br>60. Patient Perspectives<br>61. Budgeting<br>62. Ethics and Review Boards<br>63. Regulatory Considerations for New Drugs and Devices<br>64. Funding Approaches<br>65. Conflicts of Interest<br>66. Subject Recruitment<br>67. Data Management<br>68. Special Populations<br>69. Subject Adherence<br>70. Survival Analysis<br>71. Monitoring Committee in Clinical Trials<br><br>Regulatory Basics <br>72. FDA Overview<br>73. IND<br>74. New Drug Application<br>75. Devices<br>76. Orphan Drugs<br>77. Biologics<br>78. Combination Products<br>79. Foods<br>80. Cosmetics<br>81. CMC and GxP<br>82. Non-US Regulatory<br>83. Post-Market Drug Safety Monitoring<br>84. Post-Market Device Safety Monitoring<br><br>Clinical Implementation <br>85. Implementation Research<br>86. Design and Analysis<br>87. Mixed-methods Research<br>88. Population- and Setting-specific Implementation<br>89. Guideline Development<br><br>Public Health <br>90. Public Health<br>91. Epidemiology<br>92. Factors<br>93. Good Questions<br>94. Population- and Environmental-specific Considerations<br>95. Law, Policy, and Ethics<br>96. Healthcare Institutions and Systems<br>97. Public Health Institutions and Systems<br><br>Practical Resources <br>98. Presenting Data<br>99. Manuscript Preparation<br>100. Quality Improvement<br>101. Team Science and Building a Team<br>102. Patent Basics<br>103. Venture Pathways<br>104. SBIR/STTR<br>105. Sample Forms and Templates