Translational Surgery is a surgery-specific instructional guide to translational medical research that 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 bridges the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in general surgery, this book provides a clear process for understanding, designing, executing and analyzing clinical and translational research within the field.
1. Chapter 1 Introduction - p. 4 2. Chapter 2 Translational research process - p. 8 3. Chapter 3 Scientific method - p. 12 4. Chapter 4 Basic Research - p. 16 5. Chapter 5 Overview of preclinical research - p. 24 6. Chapter 6 What problem are you solving? - p. 26 7. Chapter 7 Types of intervention - p. 30 8. Chapter 8 Drug discovery and development - p. 36 9. Chapter 9 Drug testing: translating a novel immunotherapeutic from bench to bedside - p. 44 10. Chapter 10 Device discovery and prototyping - p. 54 11. Chapter 11 Medical device testing - p. 68 12. Chapter 12 Diagnostic discovery - p. 74 13. Chapter 13 Diagnostic testing - p. 80 14. Chapter 14 FDA regulating power & guidelines - p. 88 15. Chapter 15 Procedural technique development - p. 94 16. Chapter 16 Behavioral Interventions - p. 98 17. Chapter 17 Introduction to clinical research - p. 106 18. Chapter 18 The question - p. 112 19. Chapter 19 Study population - p. 122 20. Chapter 20 Outcome measurements - p. 128 21. Chapter 21 Optimizing the question - p. 134 22. Chapter 22 Basic statistical principles - p. 140 23. Chapter 23 Distributions - p. 146 24. Chapter 24 Hypothesis and error types - p. 150 25. Chapter 25 Power - p. 154 26. Chapter 26 Regression analysis - p. 158 27. Chapter 27 Continuous variable analyses - p. 166 28. Chapter 28 Categorical Variable Analyses - p. 172 29. Chapter 29 Analysis of variance - p. 178 30. Chapter 30 Correlation - p. 184 31. Chapter 31 Biases in research studies - p. 192 32. Chapter 32 Basic science statistics - p. 196 33. Chapter 33 Design principles - p. 204 34. Chapter 34 Case series - p. 208 35. Chapter 35 Case-control study—design, measures, and classic examples - p. 212 36. Chapter 36 Cohort study - p. 216 37. Chapter 37 Cross-sectional study - p. 220 38. Chapter 38 Longitudinal study - p. 224 39. Chapter 39 Designing clinical trials of surgical interventions - p. 228 40. Chapter 40 Meta-analysis - p. 236 41. Chapter 41 Cost-effectiveness research - p. 242 42. Chapter 42 Diagnostic test evaluation - p. 252 43. Chapter 43 Reliability study - p. 262 44. Chapter 44 Database research - p. 268 45. Chapter 45 Surveys and questionnaires - p. 274 46. Chapter 46 Qualitative methods and mixed methods - p. 282 47. Chapter 47 Randomized control - p. 290 48. Chapter 48 Nonrandomized control - p. 296 49. Chapter 49 Historical controls - p. 300 50. Chapter 50 Cross-over - p. 304 51. Chapter 51 Withdrawal studies - p. 308 52. Chapter 52 Factorial design - p. 316 53. Chapter 53 Group allocation - p. 322 54. Chapter 54 Hybrid design - p. 328 55. Chapter 55 Large, pragmatic trials - p. 334 56. Chapter 56 Equivalence and noninferiority - p. 340 57. Chapter 57 Adaptive - p. 348 58. Chapter 58 Principles and methods of randomization in research - p. 354 59. Chapter 59 Blinding - p. 360 60. Chapter 60 Multicenter considerations - p. 368 61. Chapter 61 Registries - p. 374 62. Chapter 62 Phases of clinical trials - p. 380 63. Chapter 63 IDEAL framework - p. 390 64. Chapter 64 Artificial intelligence methodology in clinical research - p. 396 65. Chapter 65 Patient perspectives - p. 404 66. Chapter 66 Sample size - p. 412 67. Chapter 67 Budgeting - p. 420 68. Chapter 68 Medical ethics and review boards - p. 428 69. Chapter 69 Regulatory considerations for new drugs and devices - p. 434 70. Chapter 70 Funding approaches - p. 440 71. Chapter 71 Subject recruitment - p. 446 72. Chapter 72 Data management - p. 452 73. Chapter 73 Quality control - p. 462 74. Chapter 74 Statistical software - p. 468 75. Chapter 75 Case report forms - p. 472 76. Chapter 76 Subject adherence - p. 480 77. Chapter 77 Survival analysis - p. 488 78. Chapter 78 Monitoring committees in clinical trials - p. 492 79. Chapter 79 FDA overview - p. 502 80. Chapter 80 Investigational new drugs - p. 510 81. Chapter 81 Drug development - p. 514 82. Chapter 82 Devices - p. 520 83. Chapter 83 Regulatory basics - p. 526 84. Chapter 84 Orphan drugs - p. 530 85. Chapter 85 Biopharmaceuticals - p. 536 86. Chapter 86 Combination products - p. 540 87. Chapter 87 Foods - p. 548 88. Chapter 88 Cosmetics - p. 552 89. Chapter 89 Non-US regulatory - p. 554 90. Chapter 90 Implementation research - p. 564 91. Chapter 91 Design and analysis - p. 577 92. Chapter 92 Population- and setting-specific implementation - p. 592 93. Chapter 93 Public health - p. 602 94. Chapter 94 Epidemiology - p. 610 95. Chapter 95 Factors in surgical public health and health disparities research - p. 616 96. Chapter 96 Good questions in public health research - p. 624 97. Chapter 97 Population and environmental specific considerations - p. 630 98. Chapter 98 Law, policy, and ethics - p. 636 99. Chapter 99 The role of healthcare institutions in translational surgical research - p. 642 100. Chapter 100 Public health institutions and systems - p. 648 101. Chapter 101 Data presentation - p. 662 102. Chapter 102 Manuscript preparation - p. 670 103. Chapter 103 Building a team - p. 678 104. Chapter 104 Patent basics - p. 682 105. Chapter 105 Venture pathways - p. 690 106. Chapter 106 Small Business Innovation Research and Small Business Technology Transfer - p. 694 107. Chapter 107 Sample forms and templates - p. 698 108. Index - p. 723 109. Index - Continued - p. 732 110. Index - Continued - p. 741
Translational Surgery is a surgery-specific instructional guide to translational medical research that 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 bridges the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in general surgery, this book provides a clear process for understanding, designing, executing and analyzing clinical and translational research within the field.
1. Chapter 1 Introduction - p. 4 2. Chapter 2 Translational research process - p. 8 3. Chapter 3 Scientific method - p. 12 4. Chapter 4 Basic Research - p. 16 5. Chapter 5 Overview of preclinical research - p. 24 6. Chapter 6 What problem are you solving? - p. 26 7. Chapter 7 Types of intervention - p. 30 8. Chapter 8 Drug discovery and development - p. 36 9. Chapter 9 Drug testing: translating a novel immunotherapeutic from bench to bedside - p. 44 10. Chapter 10 Device discovery and prototyping - p. 54 11. Chapter 11 Medical device testing - p. 68 12. Chapter 12 Diagnostic discovery - p. 74 13. Chapter 13 Diagnostic testing - p. 80 14. Chapter 14 FDA regulating power & guidelines - p. 88 15. Chapter 15 Procedural technique development - p. 94 16. Chapter 16 Behavioral Interventions - p. 98 17. Chapter 17 Introduction to clinical research - p. 106 18. Chapter 18 The question - p. 112 19. Chapter 19 Study population - p. 122 20. Chapter 20 Outcome measurements - p. 128 21. Chapter 21 Optimizing the question - p. 134 22. Chapter 22 Basic statistical principles - p. 140 23. Chapter 23 Distributions - p. 146 24. Chapter 24 Hypothesis and error types - p. 150 25. Chapter 25 Power - p. 154 26. Chapter 26 Regression analysis - p. 158 27. Chapter 27 Continuous variable analyses - p. 166 28. Chapter 28 Categorical Variable Analyses - p. 172 29. Chapter 29 Analysis of variance - p. 178 30. Chapter 30 Correlation - p. 184 31. Chapter 31 Biases in research studies - p. 192 32. Chapter 32 Basic science statistics - p. 196 33. Chapter 33 Design principles - p. 204 34. Chapter 34 Case series - p. 208 35. Chapter 35 Case-control study—design, measures, and classic examples - p. 212 36. Chapter 36 Cohort study - p. 216 37. Chapter 37 Cross-sectional study - p. 220 38. Chapter 38 Longitudinal study - p. 224 39. Chapter 39 Designing clinical trials of surgical interventions - p. 228 40. Chapter 40 Meta-analysis - p. 236 41. Chapter 41 Cost-effectiveness research - p. 242 42. Chapter 42 Diagnostic test evaluation - p. 252 43. Chapter 43 Reliability study - p. 262 44. Chapter 44 Database research - p. 268 45. Chapter 45 Surveys and questionnaires - p. 274 46. Chapter 46 Qualitative methods and mixed methods - p. 282 47. Chapter 47 Randomized control - p. 290 48. Chapter 48 Nonrandomized control - p. 296 49. Chapter 49 Historical controls - p. 300 50. Chapter 50 Cross-over - p. 304 51. Chapter 51 Withdrawal studies - p. 308 52. Chapter 52 Factorial design - p. 316 53. Chapter 53 Group allocation - p. 322 54. Chapter 54 Hybrid design - p. 328 55. Chapter 55 Large, pragmatic trials - p. 334 56. Chapter 56 Equivalence and noninferiority - p. 340 57. Chapter 57 Adaptive - p. 348 58. Chapter 58 Principles and methods of randomization in research - p. 354 59. Chapter 59 Blinding - p. 360 60. Chapter 60 Multicenter considerations - p. 368 61. Chapter 61 Registries - p. 374 62. Chapter 62 Phases of clinical trials - p. 380 63. Chapter 63 IDEAL framework - p. 390 64. Chapter 64 Artificial intelligence methodology in clinical research - p. 396 65. Chapter 65 Patient perspectives - p. 404 66. Chapter 66 Sample size - p. 412 67. Chapter 67 Budgeting - p. 420 68. Chapter 68 Medical ethics and review boards - p. 428 69. Chapter 69 Regulatory considerations for new drugs and devices - p. 434 70. Chapter 70 Funding approaches - p. 440 71. Chapter 71 Subject recruitment - p. 446 72. Chapter 72 Data management - p. 452 73. Chapter 73 Quality control - p. 462 74. Chapter 74 Statistical software - p. 468 75. Chapter 75 Case report forms - p. 472 76. Chapter 76 Subject adherence - p. 480 77. Chapter 77 Survival analysis - p. 488 78. Chapter 78 Monitoring committees in clinical trials - p. 492 79. Chapter 79 FDA overview - p. 502 80. Chapter 80 Investigational new drugs - p. 510 81. Chapter 81 Drug development - p. 514 82. Chapter 82 Devices - p. 520 83. Chapter 83 Regulatory basics - p. 526 84. Chapter 84 Orphan drugs - p. 530 85. Chapter 85 Biopharmaceuticals - p. 536 86. Chapter 86 Combination products - p. 540 87. Chapter 87 Foods - p. 548 88. Chapter 88 Cosmetics - p. 552 89. Chapter 89 Non-US regulatory - p. 554 90. Chapter 90 Implementation research - p. 564 91. Chapter 91 Design and analysis - p. 577 92. Chapter 92 Population- and setting-specific implementation - p. 592 93. Chapter 93 Public health - p. 602 94. Chapter 94 Epidemiology - p. 610 95. Chapter 95 Factors in surgical public health and health disparities research - p. 616 96. Chapter 96 Good questions in public health research - p. 624 97. Chapter 97 Population and environmental specific considerations - p. 630 98. Chapter 98 Law, policy, and ethics - p. 636 99. Chapter 99 The role of healthcare institutions in translational surgical research - p. 642 100. Chapter 100 Public health institutions and systems - p. 648 101. Chapter 101 Data presentation - p. 662 102. Chapter 102 Manuscript preparation - p. 670 103. Chapter 103 Building a team - p. 678 104. Chapter 104 Patent basics - p. 682 105. Chapter 105 Venture pathways - p. 690 106. Chapter 106 Small Business Innovation Research and Small Business Technology Transfer - p. 694 107. Chapter 107 Sample forms and templates - p. 698 108. Index - p. 723 109. Index - Continued - p. 732 110. Index - Continued - p. 741
