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.
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Introduction 1. Introduction 2. Translational process 3. Scientific Method Pre-Clinical 4. Overview of Preclinical Research 5. What Problem are You Solving? 6. Types of Interventions 7. Drug Discovery 8. Drug Testing 9. Device Discovery and Prototyping 10. Device Testing 11. Diagnostic Discovery 12. Other Product Types 13. Procedural Technique Development 14. Behavioral Intervention 15. Artificial Intelligence Clinical: Fundamentals 16. Introduction to Clinical Research: What is it? Why is it Needed? 17. The Question: Types of Research Questions and how to Development Them 18. Study Population: Who and Why Them? 19. Outcome Measurements: What Data is Being Collected and Why? 20. Optimizing the Question: Balancing Significance and Feasibility Statistical Principles 21. Common Issues in Analysis 22. Basic Statistical Principles 23. Hypotheses and Error Types 24. Power 25. Regression 26. Continuous Variable Analyses 27. Categorical Variable Analyses: Chi-square, Fisher Exact, Mantel Hanzel 28. Correlation 29. Biases 30. Basic Science Statistics 31. Sample Size 32. Statistical Software Clinical: Study Types 33. Design Principles: Hierarchy of Study Types 34. Case Series: Design, Measures, Classic Example 35. Case-Control Study: Design, Measures, Classic Example 36. Cohort Study: Design, Measures, Classic Example 37. Cross-section Study: Design, Measures, Classic Example 38. Longitudinal Study: Design Measures, Classic Example 39. Meta-analysis: Design, Measures, Classic Example 40. Cost-effectiveness Study: Design, Measures, Classic Example 41. Diagnostic Test Evaluation: Design, Measures, Classic Example 42. Reliability Study: Design, Measures, Classic Example 43. Database Studies: Design, Measures, Classic Example 44. Surveys and Questionnaires: Design, Measures, Classic Example 45. Qualitative Methods and Mixed Methods Clinical Trials 46. Randomized Control: Design, Measures, Classic Example 47. Historical Control: Design, Measures, Classic Example 48. Cross-Over: Design, Measures, Classic Example 49. Withdrawal Studies: Design, Measures, Classic Example 50. Factorial Design: Design, Measures, Classic Example 51. Group Allocation: Design, Measures, Classic Example 52. Hybrid Design: Design, Measures, Classic Example 53. Large, Pragmatic: Design, Measures, Classic Example 54. Equivalence and Noninferiority: Design, Measures, Classic Example 55. Adaptive: Design, Measures, Classic Example 56. Phase 0 Trials: Window of Opportunity 57. Registries 58. Phases of Clinical Trials 59. IDEAL Framework Clinical: Preparation 60. Patient Perspectives 61. Budgeting 62. Ethics and Review Boards 63. Regulatory Considerations for New Drugs and Devices 64. Funding Approaches 65. Conflicts of Interest 66. Subject Recruitment 67. Data Management 68. Special Populations 69. Subject Adherence 70. Survival Analysis 71. Monitoring Committee in Clinical Trials Regulatory Basics 72. FDA Overview 73. IND 74. New Drug Application 75. Devices 76. Orphan Drugs 77. Biologics 78. Combination Products 79. Foods 80. Cosmetics 81. CMC and GxP 82. Non-US Regulatory 83. Post-Market Drug Safety Monitoring 84. Post-Market Device Safety Monitoring Clinical Implementation 85. Implementation Research 86. Design and Analysis 87. Mixed-methods Research 88. Population- and Setting-specific Implementation 89. Guideline Development Public Health 90. Public Health 91. Epidemiology 92. Factors 93. Good Questions 94. Population- and Environmental-specific Considerations 95. Law, Policy, and Ethics 96. Healthcare Institutions and Systems 97. Public Health Institutions and Systems Practical Resources 98. Presenting Data 99. Manuscript Preparation 100. Quality Improvement 101. Team Science and Building a Team 102. Patent Basics 103. Venture Pathways 104. SBIR/STTR 105. Sample Forms and Templates
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How-to-guide for designing and conducting translational medicine research in pulmonary
Focusing on translational pulmonary diseases research, this volume covers the principles of evidence-based medicine and applies these principles to the design of translational investigations Provides a practical, straightforward approach that will help the aspiring pulmonary researchers and pulmonologists navigate challenging considerations in study design and implementation Details valuable discussions of the critical appraisal of published studies in pulmonary, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care
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Produktdetaljer

ISBN
9780323903912
Publisert
2025-06-12
Utgiver
Elsevier Science & Technology; Academic Press Inc
Vekt
450 gr
Høyde
276 mm
Bredde
216 mm
Aldersnivå
UP, P, 05, 06
Språk
Product language
Engelsk
Format
Product format
Heftet
Antall sider
610

Om bidragsyterne

Davis Hartnett, MD completed his medical degree at the Warren Alpert Medical School of Brown University and is a resident physician at Brigham and Women’s Hospital in Boston, Massachusetts in the Department of Internal Medicine. He has contributed to over 40 peer reviewed publications and over 30 academic presentations on research topics including medicolegal outcomes, healthcare access disparities, and translational medicine. Dr Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books. Larisa Tereshchenko is an Associate Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and an Adjunct Associate Professor of Electrical Engineering and Computer Science at the Cleveland State University. She has a broad background in clinical investigation, cardiology, cardiac electrophysiology and electrocardiology, biomedical engineering, biophysics, randomized controlled trials, epidemiology, biostatistics, bioinformatics, and genomics. Over the past two decades, she has led clinical studies, including randomized controlled trials, cohort, and case-control studies, and has expertise in multicenter and multidisciplinary research leadership, the building of collaborative groups, and multicohort epidemiological studies. She is an author of more than 160 original peer-reviewed manuscripts, chapters, and reviews.