Translational research is essential to the advancement of medicine. This Cardiothoracic-specific 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 cardiothoracic surgery, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research within the field.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. The scientific method - p. 11 5. Chapter 4. Basic research - p. 17 6. Part II. Pre-clinical: Discovery and development - p. P2 7. Chapter 5. Overview of preclinical research - p. 25 8. Chapter 6. What problem are you solving? - p. 31 9. Chapter 7. Types of interventions - p. 37 10. Chapter 8. Drug discovery - p. 41 11. Chapter 9. Drug testing - p. 45 12. Chapter 10. Device discovery and prototyping - p. 49 13. Chapter 11. Device testing - p. 53 14. Chapter 12. Diagnostic discovery and diagnostic testing - p. 59 15. Chapter 13. Procedural technique development in cardiac surgery - p. 63 16. Chapter 14. Artificial intelligence - p. 69 17. Part III. Clinical: Fundamentals - p. P3 18. Chapter 15. Introduction to clinical research: What is it? Why is it needed? - p. 75 19. Chapter 16. The strategy of science: How to develop a research question? - p. 83 20. Chapter 17. “Study population: Who and why them?” - p. 87 21. Chapter 18. Outcome measurements: What data are being collected and why? - p. 91 22. Chapter 19. Optimizing the research question: Balancing significance and feasibility - p. 95 23. Part IV. Statistical principles - p. P4 24. Chapter 20. Common issues in analysis - p. 99 25. Chapter 21. Basic statistical principles - p. 103 26. Chapter 22. Distribution in statistics - p. 109 27. Chapter 23. Hypotheses and error types - p. 115 28. Chapter 24. Power and sample size calculation in translational cardiothoracic surgery research - p. 119 29. Chapter 25. Regression - p. 125 30. Chapter 26. Basic continuous variable analyses: t-Test, Mann–Whitney, Wilcoxon rank and basic categorical variable analyses: Chi-square, Fisher exact, Mantel–Haenszel - p. 131 31. Chapter 27. Analysis of variance (ANOVA) - p. 137 32. Chapter 28. Correlation - p. 141 33. Chapter 29. Biases in study design and practical mitigation strategies - p. 145 34. Chapter 30. Basic science statistics - p. 151 35. Chapter 31. Sample size calculation - p. 155 36. Chapter 32. Statistical software programs in clinical and translational research: Pros, cons, and practical comparisons - p. 159 37. Part V. Clinical: Study types - p. P5 38. Chapter 33. Design principles: Hierarchy of study types - p. 167 39. Chapter 34. Case-control study: Design, measures, and classic example - p. 173 40. Chapter 35. Real-world evidence generation with cohort studies - p. 179 41. Chapter 36. Practical considerations in the design and implementation of cross-sectional studies - p. 187 42. Chapter 37. Longitudinal study: Design and measures - p. 193 43. Chapter 38. Metaanalysis: Design, measures, and classic example - p. 199 44. Chapter 39. Cost-effectiveness analysis: Design, measures, and classic example - p. 205 45. Chapter 40. Diagnostic test evaluation: Designs, measures, and a classic example - p. 213 46. Chapter 41. Reliability studies: Design, measures, classic example - p. 219 47. Chapter 42. Database studies - p. 223 48. Chapter 43. Surveys and questionnaires - p. 225 49. Chapter 44. Qualitative methods and mixed methods - p. 231 50. Part VI. Statistical trials - p. P6 51. Chapter 45. Randomized control: Design, measures, and classic example - p. 237 52. Chapter 46. Nonrandomized control studies - p. 243 53. Chapter 47. Historical control - p. 247 54. Chapter 48. Crossover: Design, measures, and classic example - p. 251 55. Chapter 49. Withdrawal studies: Design, measures, classic examples - p. 255 56. Chapter 50. Factorial design - p. 259 57. Chapter 51. Equivalence and noninferiority: Design, measures, and classic example - p. 263 58. Chapter 52. Registries - p. 267 59. Chapter 53. Phases of a clinical trial - p. 273 60. Chapter 54. IDEAL framework - p. 279 61. Part VII. Clinical: Preparation - p. P7 62. Chapter 55. Patient perspectives - p. 285 63. Chapter 56. Budgeting for research - p. 291 64. Chapter 57. Ethics and review boards - p. 297 65. Chapter 58. Regulatory considerations for new drugs and devices - p. 303 66. Chapter 59. Funding approaches - p. 311 67. Chapter 60. Conflict of interest in research - p. 315 68. Chapter 61. Patient recruitment in cardiothoracic surgery translational research - p. 319 69. Chapter 62. Data management - p. 325 70. Chapter 63. Quality control: Internal and external quality control assessment - p. 331 71. Chapter 64. Research in acute care settings - p. 337 72. Chapter 65. Special populations - p. 343 73. Chapter 66. Report forms; harm and quality of life; who, when, how, why, and consequences - p. 347 74. Chapter 67. Clinical trials—Subject adherence - p. 351 75. Chapter 68. Monitoring committee in clinical trials - p. 355 76. Part VIII. Regulatory basics - p. P8 77. Chapter 69. Investigational new drugs - p. 361 78. Chapter 70. New Drug Application - p. 367 79. Chapter 71. Devices - p. 377 80. Chapter 72. Radiation-emitting electronic products - p. 381 81. Chapter 73. Orphan drugs - p. 385 82. Chapter 74. Biologics - p. 389 83. Chapter 75. Combination products - p. 393 84. Chapter 76. Food and nutrition - p. 397 85. Chapter 77. Cosmetics - p. 401 86. Chapter 78. CMC and GxP in cardiothoracic surgery - p. 405 87. Chapter 79. Non-US regulatory - p. 409 88. Part IX. Clinical implementation - p. P9 89. Chapter 80. Postmarket drug and device safety monitoring - p. 415 90. Chapter 81. Implementation research - p. 419 91. Chapter 82. Mixed methods in cardiothoracic research - p. 425 92. Chapter 83. Population and setting specific research - p. 431 93. Part X. Public health - p. P10 94. Chapter 84. Clinical guideline development - p. 437 95. Chapter 85. Public health - p. 443 96. Chapter 86. Epidemiology - p. 447 97. Chapter 87. Factors - p. 455 98. Chapter 88. Developing good research questions in cardiothoracic surgery - p. 463 99. Chapter 89. Population and environmental specific considerations - p. 469 100. Chapter 90. Public health: Law, policy, and ethics - p. 473 101. Chapter 91. Healthcare institutions and systems - p. 477 102. Part XI. Practical resources - p. P11 103. Chapter 92. Public health institutions and systems - p. 483 104. Chapter 93. Presenting data - p. 489 105. Chapter 94. Manuscript preparation - p. 497 106. Chapter 95. Promoting research in cardiothoracic surgery: Metrics, academic advancement, and navigating benefits and risks - p. 503 107. Chapter 96. Venture pathways - p. 509 108. Chapter 97. Building a scientific team - p. 517 109. Chapter 98. Patent basics - p. 523 110. Chapter 99. Venture pathways - p. 527 111. Chapter 100. NIH grants - p. 533 112. Chapter 101. Essential forms and templates for research planning and reporting - p. 543 113. Glossary - p. 551 114. Index - p. 565
Translational research is essential to the advancement of medicine. This Cardiothoracic-specific 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 cardiothoracic surgery, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research within the field.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. The scientific method - p. 11 5. Chapter 4. Basic research - p. 17 6. Part II. Pre-clinical: Discovery and development - p. P2 7. Chapter 5. Overview of preclinical research - p. 25 8. Chapter 6. What problem are you solving? - p. 31 9. Chapter 7. Types of interventions - p. 37 10. Chapter 8. Drug discovery - p. 41 11. Chapter 9. Drug testing - p. 45 12. Chapter 10. Device discovery and prototyping - p. 49 13. Chapter 11. Device testing - p. 53 14. Chapter 12. Diagnostic discovery and diagnostic testing - p. 59 15. Chapter 13. Procedural technique development in cardiac surgery - p. 63 16. Chapter 14. Artificial intelligence - p. 69 17. Part III. Clinical: Fundamentals - p. P3 18. Chapter 15. Introduction to clinical research: What is it? Why is it needed? - p. 75 19. Chapter 16. The strategy of science: How to develop a research question? - p. 83 20. Chapter 17. “Study population: Who and why them?” - p. 87 21. Chapter 18. Outcome measurements: What data are being collected and why? - p. 91 22. Chapter 19. Optimizing the research question: Balancing significance and feasibility - p. 95 23. Part IV. Statistical principles - p. P4 24. Chapter 20. Common issues in analysis - p. 99 25. Chapter 21. Basic statistical principles - p. 103 26. Chapter 22. Distribution in statistics - p. 109 27. Chapter 23. Hypotheses and error types - p. 115 28. Chapter 24. Power and sample size calculation in translational cardiothoracic surgery research - p. 119 29. Chapter 25. Regression - p. 125 30. Chapter 26. Basic continuous variable analyses: t-Test, Mann–Whitney, Wilcoxon rank and basic categorical variable analyses: Chi-square, Fisher exact, Mantel–Haenszel - p. 131 31. Chapter 27. Analysis of variance (ANOVA) - p. 137 32. Chapter 28. Correlation - p. 141 33. Chapter 29. Biases in study design and practical mitigation strategies - p. 145 34. Chapter 30. Basic science statistics - p. 151 35. Chapter 31. Sample size calculation - p. 155 36. Chapter 32. Statistical software programs in clinical and translational research: Pros, cons, and practical comparisons - p. 159 37. Part V. Clinical: Study types - p. P5 38. Chapter 33. Design principles: Hierarchy of study types - p. 167 39. Chapter 34. Case-control study: Design, measures, and classic example - p. 173 40. Chapter 35. Real-world evidence generation with cohort studies - p. 179 41. Chapter 36. Practical considerations in the design and implementation of cross-sectional studies - p. 187 42. Chapter 37. Longitudinal study: Design and measures - p. 193 43. Chapter 38. Metaanalysis: Design, measures, and classic example - p. 199 44. Chapter 39. Cost-effectiveness analysis: Design, measures, and classic example - p. 205 45. Chapter 40. Diagnostic test evaluation: Designs, measures, and a classic example - p. 213 46. Chapter 41. Reliability studies: Design, measures, classic example - p. 219 47. Chapter 42. Database studies - p. 223 48. Chapter 43. Surveys and questionnaires - p. 225 49. Chapter 44. Qualitative methods and mixed methods - p. 231 50. Part VI. Statistical trials - p. P6 51. Chapter 45. Randomized control: Design, measures, and classic example - p. 237 52. Chapter 46. Nonrandomized control studies - p. 243 53. Chapter 47. Historical control - p. 247 54. Chapter 48. Crossover: Design, measures, and classic example - p. 251 55. Chapter 49. Withdrawal studies: Design, measures, classic examples - p. 255 56. Chapter 50. Factorial design - p. 259 57. Chapter 51. Equivalence and noninferiority: Design, measures, and classic example - p. 263 58. Chapter 52. Registries - p. 267 59. Chapter 53. Phases of a clinical trial - p. 273 60. Chapter 54. IDEAL framework - p. 279 61. Part VII. Clinical: Preparation - p. P7 62. Chapter 55. Patient perspectives - p. 285 63. Chapter 56. Budgeting for research - p. 291 64. Chapter 57. Ethics and review boards - p. 297 65. Chapter 58. Regulatory considerations for new drugs and devices - p. 303 66. Chapter 59. Funding approaches - p. 311 67. Chapter 60. Conflict of interest in research - p. 315 68. Chapter 61. Patient recruitment in cardiothoracic surgery translational research - p. 319 69. Chapter 62. Data management - p. 325 70. Chapter 63. Quality control: Internal and external quality control assessment - p. 331 71. Chapter 64. Research in acute care settings - p. 337 72. Chapter 65. Special populations - p. 343 73. Chapter 66. Report forms; harm and quality of life; who, when, how, why, and consequences - p. 347 74. Chapter 67. Clinical trials—Subject adherence - p. 351 75. Chapter 68. Monitoring committee in clinical trials - p. 355 76. Part VIII. Regulatory basics - p. P8 77. Chapter 69. Investigational new drugs - p. 361 78. Chapter 70. New Drug Application - p. 367 79. Chapter 71. Devices - p. 377 80. Chapter 72. Radiation-emitting electronic products - p. 381 81. Chapter 73. Orphan drugs - p. 385 82. Chapter 74. Biologics - p. 389 83. Chapter 75. Combination products - p. 393 84. Chapter 76. Food and nutrition - p. 397 85. Chapter 77. Cosmetics - p. 401 86. Chapter 78. CMC and GxP in cardiothoracic surgery - p. 405 87. Chapter 79. Non-US regulatory - p. 409 88. Part IX. Clinical implementation - p. P9 89. Chapter 80. Postmarket drug and device safety monitoring - p. 415 90. Chapter 81. Implementation research - p. 419 91. Chapter 82. Mixed methods in cardiothoracic research - p. 425 92. Chapter 83. Population and setting specific research - p. 431 93. Part X. Public health - p. P10 94. Chapter 84. Clinical guideline development - p. 437 95. Chapter 85. Public health - p. 443 96. Chapter 86. Epidemiology - p. 447 97. Chapter 87. Factors - p. 455 98. Chapter 88. Developing good research questions in cardiothoracic surgery - p. 463 99. Chapter 89. Population and environmental specific considerations - p. 469 100. Chapter 90. Public health: Law, policy, and ethics - p. 473 101. Chapter 91. Healthcare institutions and systems - p. 477 102. Part XI. Practical resources - p. P11 103. Chapter 92. Public health institutions and systems - p. 483 104. Chapter 93. Presenting data - p. 489 105. Chapter 94. Manuscript preparation - p. 497 106. Chapter 95. Promoting research in cardiothoracic surgery: Metrics, academic advancement, and navigating benefits and risks - p. 503 107. Chapter 96. Venture pathways - p. 509 108. Chapter 97. Building a scientific team - p. 517 109. Chapter 98. Patent basics - p. 523 110. Chapter 99. Venture pathways - p. 527 111. Chapter 100. NIH grants - p. 533 112. Chapter 101. Essential forms and templates for research planning and reporting - p. 543 113. Glossary - p. 551 114. Index - p. 565
