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.
1. Part I. Introduction - p. 1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process in research - p. 7 4. Chapter 3. The scientific method - p. 11 5. Part II. Pre-clinical - p. 17 6. Chapter 4. Overview of preclinical research - p. 19 7. Chapter 5. What problem are you solving? - p. 23 8. Chapter 6. Types of interventions - p. 29 9. Chapter 7. Drug discovery - p. 33 10. Chapter 8. From bench to bedside: Drug testing and development - p. 37 11. Chapter 9. Device discovery and prototyping - p. 43 12. Chapter 10. Device testing - p. 51 13. Chapter 11. Diagnostic discovery - p. 57 14. Chapter 12. Other product types - p. 61 15. Chapter 13. Procedural technique development - p. 65 16. Chapter 14. Behavioral intervention - p. 71 17. Chapter 15. Artificial intelligence - p. 77 18. Part III. Clinical: Fundamentals - p. 83 19. Chapter 16. Introduction to clinical research: What is it? Why is it needed? - p. 85 20. Chapter 17. The question: Types of research questions and how to develop them - p. 87 21. Chapter 18. Study population: Who and why them? - p. 91 22. Chapter 19. Outcome measurements: What data is being collected and why? - p. 95 23. Chapter 20. Optimizing the question: Balancing significance and feasibility - p. 99 24. Part IV. Statistical principles - p. 103 25. Chapter 21. Issues in analysis - p. 105 26. Chapter 22. Basic statistical principles - p. 109 27. Chapter 23. Hypothesis and error types - p. 115 28. Chapter 24. Power - p. 119 29. Chapter 25. Regression - p. 123 30. Chapter 26. Continuous variable analyses - p. 133 31. Chapter 27. Categorical variable analyses: Chi-square, Fisher exact, Mantel Haenszel test - p. 141 32. Chapter 28. Correlation - p. 149 33. Chapter 29. Bias - p. 153 34. Chapter 30. Basic science statistics - p. 161 35. Chapter 31. Sample size - p. 167 36. Chapter 32. Statistical software - p. 171 37. Part V. Clinical: Study types - p. 181 38. Chapter 33. Design principles: Hierarchy of study types - p. 183 39. Chapter 34. Case series: Design, measures, and classic examples - p. 187 40. Chapter 35. Case-control study: Design, measures, classic example - p. 193 41. Chapter 36. Cohort study: Design, measures, classic example - p. 199 42. Chapter 37. Cross-sectional studies - p. 203 43. Chapter 38. Longitudinal study: Design measures, classic example - p. 207 44. Chapter 39. Meta-analysis: Design, measures, classic example - p. 213 45. Chapter 40. Cost-effectiveness study: Design, measures, classic example - p. 219 46. Chapter 41. Diagnostic test evaluation: Design, measures, classic example - p. 223 47. Chapter 42. Reliability study: Design, measures, classic example - p. 229 48. Chapter 43. Database studies - p. 235 49. Chapter 44. Surveys and questionnaires - p. 241 50. Chapter 45. Qualitative methods and mixed methods - p. 247 51. Part VI. Clinical trials - p. 253 52. Chapter 46. Randomized control trials: Design, measures, and classic examples - p. 255 53. Chapter 47. Historical control: Design, measures, classic example - p. 261 54. Chapter 48. Crossover: Design, measures, a classic example - p. 265 55. Chapter 49. Withdrawal studies: Design, measures, and classic examples - p. 271 56. Chapter 50. The fundamentals of factorial design: Structure, challenges and notable applications - p. 277 57. Chapter 51. Group allocation - p. 283 58. Chapter 53. Large, pragmatic: Design, measures, classic example - p. 293 59. Chapter 54. Equivalence and noninferiority: Design, measures, classic examples - p. 297 60. Chapter 55. An overview of adaptive study design - p. 303 61. Chapter 56. Phase 0 trials: The window of opportunity - p. 309 62. Chapter 57. Registries - p. 319 63. Chapter 58. Phases of clinical trials - p. 323 64. Chapter 59. IDEAL framework: Framework for describing the stages of innovation in surgery - p. 329 65. Part VII. Clinical: Preparation - p. 333 66. Chapter 60. Patient perspectives - p. 335 67. Chapter 61. Budgeting - p. 339 68. Chapter 62. Ethics and review boards - p. 343 69. Chapter 63. Regulatory considerations for new drugs and devices - p. 349 70. Chapter 64. Funding approaches - p. 353 71. Chapter 65. Conflict of interest - p. 357 72. Chapter 66. Subject recruitment - p. 361 73. Chapter 67. Data management - p. 365 74. Chapter 68. Special populations - p. 369 75. Chapter 69. Subject adherence - p. 373 76. Chapter 70. Survival analysis - p. 379 77. Chapter 71. Monitoring committee in clinical trials - p. 383 78. Part VIII. Regulatory basics - p. 387 79. Chapter 72. An Overview of the United States Food and Drug Administration - p. 389 80. Chapter 73. Investigational new drug - p. 395 81. Chapter 74. FDA new drug applications in translational pulmonology - p. 401 82. Chapter 75. Devices - p. 405 83. Chapter 76. Orphan drugs - p. 409 84. Chapter 77. Biologics - p. 413 85. Chapter 78. Combination products - p. 419 86. Chapter 79. Foods - p. 425 87. Chapter 80. Regulation of cosmetics by the FDA - p. 433 88. Chapter 81. CMC and GxP - p. 437 89. Chapter 82. Navigating global regulatory pathways for COVID-19 therapy approval - p. 443 90. Chapter 83. Postmarket drug safety monitoring - p. 447 91. Chapter 84. Postmarket Device Safety Monitoring - p. 451 92. Part IX. Clinical implementation - p. 455 93. Chapter 85. Implementation research - p. 457 94. Chapter 86. Design and analysis - p. 463 95. Chapter 87. Mixed-methods research - p. 467 96. Chapter 88. Population- and setting-specific implementation - p. 475 97. Chapter 89. Guideline development - p. 479 98. Part X. Public health - p. 483 99. Chapter 90. Public health - p. 485 100. Chapter 91. Epidemiology - p. 489 101. Chapter 92. Factors - p. 493 102. Chapter 93. Formulating a research question - p. 497 103. Chapter 94. Population and environmental specific considerations - p. 503 104. Chapter 95. Laws, policy, and ethics - p. 507 105. Chapter 96. Healthcare institutions and systems - p. 511 106. Chapter 97. Public health institutions and systems - p. 519 107. Part XI. Practical resources - p. 523 108. Chapter 98. Effectively presenting data: A keystone of translational research - p. 525 109. Chapter 99. Manuscript preparation - p. 529 110. Chapter 100. Quality improvement - p. 535 111. Chapter 101. Team science and building a team - p. 543 112. Chapter 102. Patent basics - p. 547 113. Chapter 103. Venture pathways - p. 555 114. Chapter 104. SBIR/STTR - p. 559 115. Chapter 105. Sample forms and templates - p. 565 116. Glossary - p. 571 117. Index - p. 583
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.
1. Part I. Introduction - p. 1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process in research - p. 7 4. Chapter 3. The scientific method - p. 11 5. Part II. Pre-clinical - p. 17 6. Chapter 4. Overview of preclinical research - p. 19 7. Chapter 5. What problem are you solving? - p. 23 8. Chapter 6. Types of interventions - p. 29 9. Chapter 7. Drug discovery - p. 33 10. Chapter 8. From bench to bedside: Drug testing and development - p. 37 11. Chapter 9. Device discovery and prototyping - p. 43 12. Chapter 10. Device testing - p. 51 13. Chapter 11. Diagnostic discovery - p. 57 14. Chapter 12. Other product types - p. 61 15. Chapter 13. Procedural technique development - p. 65 16. Chapter 14. Behavioral intervention - p. 71 17. Chapter 15. Artificial intelligence - p. 77 18. Part III. Clinical: Fundamentals - p. 83 19. Chapter 16. Introduction to clinical research: What is it? Why is it needed? - p. 85 20. Chapter 17. The question: Types of research questions and how to develop them - p. 87 21. Chapter 18. Study population: Who and why them? - p. 91 22. Chapter 19. Outcome measurements: What data is being collected and why? - p. 95 23. Chapter 20. Optimizing the question: Balancing significance and feasibility - p. 99 24. Part IV. Statistical principles - p. 103 25. Chapter 21. Issues in analysis - p. 105 26. Chapter 22. Basic statistical principles - p. 109 27. Chapter 23. Hypothesis and error types - p. 115 28. Chapter 24. Power - p. 119 29. Chapter 25. Regression - p. 123 30. Chapter 26. Continuous variable analyses - p. 133 31. Chapter 27. Categorical variable analyses: Chi-square, Fisher exact, Mantel Haenszel test - p. 141 32. Chapter 28. Correlation - p. 149 33. Chapter 29. Bias - p. 153 34. Chapter 30. Basic science statistics - p. 161 35. Chapter 31. Sample size - p. 167 36. Chapter 32. Statistical software - p. 171 37. Part V. Clinical: Study types - p. 181 38. Chapter 33. Design principles: Hierarchy of study types - p. 183 39. Chapter 34. Case series: Design, measures, and classic examples - p. 187 40. Chapter 35. Case-control study: Design, measures, classic example - p. 193 41. Chapter 36. Cohort study: Design, measures, classic example - p. 199 42. Chapter 37. Cross-sectional studies - p. 203 43. Chapter 38. Longitudinal study: Design measures, classic example - p. 207 44. Chapter 39. Meta-analysis: Design, measures, classic example - p. 213 45. Chapter 40. Cost-effectiveness study: Design, measures, classic example - p. 219 46. Chapter 41. Diagnostic test evaluation: Design, measures, classic example - p. 223 47. Chapter 42. Reliability study: Design, measures, classic example - p. 229 48. Chapter 43. Database studies - p. 235 49. Chapter 44. Surveys and questionnaires - p. 241 50. Chapter 45. Qualitative methods and mixed methods - p. 247 51. Part VI. Clinical trials - p. 253 52. Chapter 46. Randomized control trials: Design, measures, and classic examples - p. 255 53. Chapter 47. Historical control: Design, measures, classic example - p. 261 54. Chapter 48. Crossover: Design, measures, a classic example - p. 265 55. Chapter 49. Withdrawal studies: Design, measures, and classic examples - p. 271 56. Chapter 50. The fundamentals of factorial design: Structure, challenges and notable applications - p. 277 57. Chapter 51. Group allocation - p. 283 58. Chapter 53. Large, pragmatic: Design, measures, classic example - p. 293 59. Chapter 54. Equivalence and noninferiority: Design, measures, classic examples - p. 297 60. Chapter 55. An overview of adaptive study design - p. 303 61. Chapter 56. Phase 0 trials: The window of opportunity - p. 309 62. Chapter 57. Registries - p. 319 63. Chapter 58. Phases of clinical trials - p. 323 64. Chapter 59. IDEAL framework: Framework for describing the stages of innovation in surgery - p. 329 65. Part VII. Clinical: Preparation - p. 333 66. Chapter 60. Patient perspectives - p. 335 67. Chapter 61. Budgeting - p. 339 68. Chapter 62. Ethics and review boards - p. 343 69. Chapter 63. Regulatory considerations for new drugs and devices - p. 349 70. Chapter 64. Funding approaches - p. 353 71. Chapter 65. Conflict of interest - p. 357 72. Chapter 66. Subject recruitment - p. 361 73. Chapter 67. Data management - p. 365 74. Chapter 68. Special populations - p. 369 75. Chapter 69. Subject adherence - p. 373 76. Chapter 70. Survival analysis - p. 379 77. Chapter 71. Monitoring committee in clinical trials - p. 383 78. Part VIII. Regulatory basics - p. 387 79. Chapter 72. An Overview of the United States Food and Drug Administration - p. 389 80. Chapter 73. Investigational new drug - p. 395 81. Chapter 74. FDA new drug applications in translational pulmonology - p. 401 82. Chapter 75. Devices - p. 405 83. Chapter 76. Orphan drugs - p. 409 84. Chapter 77. Biologics - p. 413 85. Chapter 78. Combination products - p. 419 86. Chapter 79. Foods - p. 425 87. Chapter 80. Regulation of cosmetics by the FDA - p. 433 88. Chapter 81. CMC and GxP - p. 437 89. Chapter 82. Navigating global regulatory pathways for COVID-19 therapy approval - p. 443 90. Chapter 83. Postmarket drug safety monitoring - p. 447 91. Chapter 84. Postmarket Device Safety Monitoring - p. 451 92. Part IX. Clinical implementation - p. 455 93. Chapter 85. Implementation research - p. 457 94. Chapter 86. Design and analysis - p. 463 95. Chapter 87. Mixed-methods research - p. 467 96. Chapter 88. Population- and setting-specific implementation - p. 475 97. Chapter 89. Guideline development - p. 479 98. Part X. Public health - p. 483 99. Chapter 90. Public health - p. 485 100. Chapter 91. Epidemiology - p. 489 101. Chapter 92. Factors - p. 493 102. Chapter 93. Formulating a research question - p. 497 103. Chapter 94. Population and environmental specific considerations - p. 503 104. Chapter 95. Laws, policy, and ethics - p. 507 105. Chapter 96. Healthcare institutions and systems - p. 511 106. Chapter 97. Public health institutions and systems - p. 519 107. Part XI. Practical resources - p. 523 108. Chapter 98. Effectively presenting data: A keystone of translational research - p. 525 109. Chapter 99. Manuscript preparation - p. 529 110. Chapter 100. Quality improvement - p. 535 111. Chapter 101. Team science and building a team - p. 543 112. Chapter 102. Patent basics - p. 547 113. Chapter 103. Venture pathways - p. 555 114. Chapter 104. SBIR/STTR - p. 559 115. Chapter 105. Sample forms and templates - p. 565 116. Glossary - p. 571 117. Index - p. 583
