Translational Radiation Oncology covers the principles of evidence-based medicine and applies them to the design of translational research. The book provides valuable discussions on the critical appraisal of published studies and recent developments in radiation oncology, allowing readers to learn how to evaluate the quality of such studies with respect to measuring outcomes and make effective use of all types of evidence. By reading this book, researchers have access to a practical approach to help them navigate challenging considerations in study design and implementation.
It is a valuable resource for researchers, oncologists and members of biomedical field who want to understand more about translational research applied to the field of radiation oncology. Translational medicine serves as an indispensable tool in grant writing and funding efforts, so understanding how to apply its principles to research is necessary to guarantee that results will be impactful to patients.
1. Chapter 1 : Introduction - p. Page xiv 2. Chapter 2 : Translational process - p. Page 4 3. Chapter 3 : Scientific method - p. Page 10 4. Chapter 4 : Basic research - p. Page 13 5. Chapter 5 : Overview of preclinical research - p. Page 18 6. Chapter 6 : What problem are you solving? - p. Page 24 7. Chapter 7 : Types of interventions: drug, device, diagnostic, procedural technique, or behavior change - p. Page 30 8. Chapter 8 : Drug discovery - p. Page 35 9. Chapter 9 : Drug testing - p. Page 43 10. Chapter 10 : Device discovery and prototyping - p. Page 48 11. Chapter 11 : Device testing - p. Page 53 12. Chapter 12 : Diagnostic discovery - p. Page 58 13. Chapter 13 : Diagnostic testing - p. Page 63 14. Chapter 14 : Procedural technique development in radiation oncology - p. Page 70 15. Chapter 15 : Behavioral intervention studies in radiation oncology - p. Page 79 16. Chapter 16 : Artificial intelligence - p. Page 88 17. Chapter 17 : Introduction to clinical research: What is it? Why is it needed? - p. Page 96 18. Chapter 18 : The question: types of research questions and how to develop them - p. Page 104 19. Chapter 19 : Defining the study population: who and why? - p. Page 106 20. Chapter 20 : Outcome measurements: What data are being collected and why? - p. Page 108 21. Chapter 21 : Optimizing the question: Balancing significance and feasibility: Will the findings affect change? Can that change be implemented in clinical practice? - p. Page 111 22. Chapter 22 : Statistical efficiency in study design - p. Page 118 23. Chapter 23 : Basic statistical principles - p. Page 122 24. Chapter 24 : Distribution - p. Page 128 25. Chapter 25 : Hypotheses and error types - p. Page 133 26. Chapter 26 : Power - p. Page 137 27. Chapter 27 : Regression - p. Page 142 28. Chapter 28 : Continuous variable analyses: t-test, Mann–Whitney, Wilcoxin rank - p. Page 152 29. Chapter 29 : Categorical variable analyses: Chi-square, Fisher's exact, Mantel–Haenszel - p. Page 163 30. Chapter 30 : Analysis of variance - p. Page 170 31. Chapter 31 : Correlation - p. Page 177 32. Chapter 32 : Biases - p. Page 183 33. Chapter 33 : Methods and statistics for high-throughput data in basic science - p. Page 189 34. Chapter 34 : Sample size - p. Page 196 35. Chapter 35 : Statistical software - p. Page 202 36. Chapter 36 : Design principles: hierarchy of study types - p. Page 209 37. Chapter 37 : Case series: design, measures, classic example - p. Page 216 38. Chapter 38 : Case-control study - p. Page 221 39. Chapter 39 : Cohort studies - p. Page 229 40. Chapter 40 : Cross-sectional study - p. Page 235 41. Chapter 41 : Longitudinal studies - p. Page 240 42. Chapter 42 : Meta-analysis: design, measures, real-world examples - p. Page 248 43. Chapter 43 : A cost-effectiveness study: design, measures, classic example - p. Page 255 44. Chapter 44 : Diagnostic test evaluation - p. Page 260 45. Chapter 45 : Reliability study - p. Page 266 46. Chapter 46 : Database studies - p. Page 273 47. Chapter 47 : Surveys and questionnaires: design, measures, and classical examples - p. Page 281 48. Chapter 48 : Qualitative methods and mixed-methods: design, measures, and classic examples - p. Page 289 49. Chapter 49 : Visual analytics: design, measures, classic example - p. Page 294 50. Chapter 50 : Randomized controlled trial - p. Page 302 51. Chapter 51 : Nonrandomized trials in clinical oncology - p. Page 311 52. Chapter 52 : Historical control: design and measures - p. Page 316 53. Chapter 53 : Crossover study - p. Page 321 54. Chapter 54 : Factorial design - p. Page 325 55. Chapter 55 : Large, pragmatic: design, measures, classic example - p. Page 330 56. Chapter 56 : Equivalence and non-inferiority trials: design, measures, classic example - p. Page 335 57. Chapter 57 : Adaptive designs - p. Page 343 58. Chapter 58 : Randomization: fixed or adaptive procedures - p. Page 348 59. Chapter 59 : Blinding: who and why? - p. Page 352 60. Chapter 60 : Phase 0 trials: windows of opportunity - p. Page 355 61. Chapter 61 : Registries - p. Page 359 62. Chapter 62 : Phases of clinical trials: overview - p. Page 366 63. Chapter 63 : IDEAL framework for innovations in surgery - p. Page 374 64. Chapter 64 : Patient perspectives - p. Page 379 65. Chapter 65 : Ethics and review boards: Guiding principles, permissible and non-permissible questions, IRB process - p. Page 386 66. Chapter 66 : Regulatory considerations for new drugs and devices - p. Page 391 67. Chapter 67 : Funding approaches - p. Page 396 68. Chapter 68 : Conflicts of interest - p. Page 404 69. Chapter 69 : Clinical preparation—subject recruitment - p. Page 407 70. Chapter 70 : Quality control - p. Page 415 71. Chapter 71 : Translational radiation research—special populations - p. Page 421 72. Chapter 72 : Case report forms - p. Page 428 73. Chapter 73 : Subject adherence: are the subjects following the protocol? If not, how to assess and analyze (intention to treat vs. per protocol) - p. Page 436 74. Chapter 74 : Survival analysis - p. Page 442 75. Chapter 75 : FDA overview - p. Page 448 76. Chapter 76 : Investigational New Drug Applications - p. Page 457 77. Chapter 77 : New drug application - p. Page 463 78. Chapter 78 : Regulatory basics - medical devices for the US market - p. Page 468 79. Chapter 79 : Regulatory basics: radiation-emitting electronic products - p. Page 476 80. Chapter 80 : Orphan drugs - p. Page 483 81. Chapter 81 : Biologics License Application - p. Page 487 82. Chapter 82 : Combination products - p. Page 491 83. Chapter 83 : Chemistry, manufacturing, and controls - p. Page 501 84. Chapter 84 : Postmarket drug safety monitoring - p. Page 506 85. Chapter 85 : Postmarket device safety monitoring - p. Page 511 86. Chapter 86 : Implementation research overview - p. Page 517 87. Chapter 87 : Design and analysis - p. Page 525 88. Chapter 88 : Mixed-methods research - p. Page 530 89. Chapter 89 : Clinical guideline development - p. Page 535 90. Chapter 90 : History of the Cooperative Group system (National Clinical Trials Network) - p. Page 542 91. Chapter 91 : Digital health - p. Page 547 92. Chapter 92 : Public health and cancer: an overview - p. Page 555 93. Chapter 93 : Epidemiology - p. Page 563 94. Chapter 94 : Multifactorial considerations of human health and public health in oncology - p. Page 572 95. Chapter 95 : Good questions - p. Page 577 96. Chapter 96 : Population and environmental-specific considerations - p. Page 584 97. Chapter 97 : Public health law - p. Page 588 98. Chapter 98 : Public health institutions and systems - p. Page 595 99. Chapter 99 : Diversity, equity, and inclusion - p. Page 600 100. Chapter 100 : Ethics in scientific publishing - p. Page 609 101. Chapter 101 : Presenting data - p. Page 618 102. Chapter 102 : Manuscript preparation - p. Page 627 103. Chapter 103 : Promoting research - p. Page 632 104. Chapter 104 : Social media and clinical trials - p. Page 636 105. Chapter 105 : Quality improvement - p. Page 638 106. Chapter 106 : Education to translate research into practice - p. Page 644 107. Chapter 107 : Team science and building a team - p. Page 652 108. Chapter 108 : Promoting research: why, how, indices h-index, m-index, etc - p. Page 656 109. Chapter 109 : Venture Pathways for aspiring radiation oncologists - p. Page 658 110. Chapter 110 : Developing Translational Ventures with the Federal Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Seed Funds - p. Page 667 111. Chapter 111 : Sample forms and templates - p. Page 672 112. Glossary - p. Page 679 113. Index - p. Page 679
Translational Radiation Oncology covers the principles of evidence-based medicine and applies them to the design of translational research. The book provides valuable discussions on the critical appraisal of published studies and recent developments in radiation oncology, allowing readers to learn how to evaluate the quality of such studies with respect to measuring outcomes and make effective use of all types of evidence. By reading this book, researchers have access to a practical approach to help them navigate challenging considerations in study design and implementation.
It is a valuable resource for researchers, oncologists and members of biomedical field who want to understand more about translational research applied to the field of radiation oncology. Translational medicine serves as an indispensable tool in grant writing and funding efforts, so understanding how to apply its principles to research is necessary to guarantee that results will be impactful to patients.
1. Chapter 1 : Introduction - p. Page xiv 2. Chapter 2 : Translational process - p. Page 4 3. Chapter 3 : Scientific method - p. Page 10 4. Chapter 4 : Basic research - p. Page 13 5. Chapter 5 : Overview of preclinical research - p. Page 18 6. Chapter 6 : What problem are you solving? - p. Page 24 7. Chapter 7 : Types of interventions: drug, device, diagnostic, procedural technique, or behavior change - p. Page 30 8. Chapter 8 : Drug discovery - p. Page 35 9. Chapter 9 : Drug testing - p. Page 43 10. Chapter 10 : Device discovery and prototyping - p. Page 48 11. Chapter 11 : Device testing - p. Page 53 12. Chapter 12 : Diagnostic discovery - p. Page 58 13. Chapter 13 : Diagnostic testing - p. Page 63 14. Chapter 14 : Procedural technique development in radiation oncology - p. Page 70 15. Chapter 15 : Behavioral intervention studies in radiation oncology - p. Page 79 16. Chapter 16 : Artificial intelligence - p. Page 88 17. Chapter 17 : Introduction to clinical research: What is it? Why is it needed? - p. Page 96 18. Chapter 18 : The question: types of research questions and how to develop them - p. Page 104 19. Chapter 19 : Defining the study population: who and why? - p. Page 106 20. Chapter 20 : Outcome measurements: What data are being collected and why? - p. Page 108 21. Chapter 21 : Optimizing the question: Balancing significance and feasibility: Will the findings affect change? Can that change be implemented in clinical practice? - p. Page 111 22. Chapter 22 : Statistical efficiency in study design - p. Page 118 23. Chapter 23 : Basic statistical principles - p. Page 122 24. Chapter 24 : Distribution - p. Page 128 25. Chapter 25 : Hypotheses and error types - p. Page 133 26. Chapter 26 : Power - p. Page 137 27. Chapter 27 : Regression - p. Page 142 28. Chapter 28 : Continuous variable analyses: t-test, Mann–Whitney, Wilcoxin rank - p. Page 152 29. Chapter 29 : Categorical variable analyses: Chi-square, Fisher's exact, Mantel–Haenszel - p. Page 163 30. Chapter 30 : Analysis of variance - p. Page 170 31. Chapter 31 : Correlation - p. Page 177 32. Chapter 32 : Biases - p. Page 183 33. Chapter 33 : Methods and statistics for high-throughput data in basic science - p. Page 189 34. Chapter 34 : Sample size - p. Page 196 35. Chapter 35 : Statistical software - p. Page 202 36. Chapter 36 : Design principles: hierarchy of study types - p. Page 209 37. Chapter 37 : Case series: design, measures, classic example - p. Page 216 38. Chapter 38 : Case-control study - p. Page 221 39. Chapter 39 : Cohort studies - p. Page 229 40. Chapter 40 : Cross-sectional study - p. Page 235 41. Chapter 41 : Longitudinal studies - p. Page 240 42. Chapter 42 : Meta-analysis: design, measures, real-world examples - p. Page 248 43. Chapter 43 : A cost-effectiveness study: design, measures, classic example - p. Page 255 44. Chapter 44 : Diagnostic test evaluation - p. Page 260 45. Chapter 45 : Reliability study - p. Page 266 46. Chapter 46 : Database studies - p. Page 273 47. Chapter 47 : Surveys and questionnaires: design, measures, and classical examples - p. Page 281 48. Chapter 48 : Qualitative methods and mixed-methods: design, measures, and classic examples - p. Page 289 49. Chapter 49 : Visual analytics: design, measures, classic example - p. Page 294 50. Chapter 50 : Randomized controlled trial - p. Page 302 51. Chapter 51 : Nonrandomized trials in clinical oncology - p. Page 311 52. Chapter 52 : Historical control: design and measures - p. Page 316 53. Chapter 53 : Crossover study - p. Page 321 54. Chapter 54 : Factorial design - p. Page 325 55. Chapter 55 : Large, pragmatic: design, measures, classic example - p. Page 330 56. Chapter 56 : Equivalence and non-inferiority trials: design, measures, classic example - p. Page 335 57. Chapter 57 : Adaptive designs - p. Page 343 58. Chapter 58 : Randomization: fixed or adaptive procedures - p. Page 348 59. Chapter 59 : Blinding: who and why? - p. Page 352 60. Chapter 60 : Phase 0 trials: windows of opportunity - p. Page 355 61. Chapter 61 : Registries - p. Page 359 62. Chapter 62 : Phases of clinical trials: overview - p. Page 366 63. Chapter 63 : IDEAL framework for innovations in surgery - p. Page 374 64. Chapter 64 : Patient perspectives - p. Page 379 65. Chapter 65 : Ethics and review boards: Guiding principles, permissible and non-permissible questions, IRB process - p. Page 386 66. Chapter 66 : Regulatory considerations for new drugs and devices - p. Page 391 67. Chapter 67 : Funding approaches - p. Page 396 68. Chapter 68 : Conflicts of interest - p. Page 404 69. Chapter 69 : Clinical preparation—subject recruitment - p. Page 407 70. Chapter 70 : Quality control - p. Page 415 71. Chapter 71 : Translational radiation research—special populations - p. Page 421 72. Chapter 72 : Case report forms - p. Page 428 73. Chapter 73 : Subject adherence: are the subjects following the protocol? If not, how to assess and analyze (intention to treat vs. per protocol) - p. Page 436 74. Chapter 74 : Survival analysis - p. Page 442 75. Chapter 75 : FDA overview - p. Page 448 76. Chapter 76 : Investigational New Drug Applications - p. Page 457 77. Chapter 77 : New drug application - p. Page 463 78. Chapter 78 : Regulatory basics - medical devices for the US market - p. Page 468 79. Chapter 79 : Regulatory basics: radiation-emitting electronic products - p. Page 476 80. Chapter 80 : Orphan drugs - p. Page 483 81. Chapter 81 : Biologics License Application - p. Page 487 82. Chapter 82 : Combination products - p. Page 491 83. Chapter 83 : Chemistry, manufacturing, and controls - p. Page 501 84. Chapter 84 : Postmarket drug safety monitoring - p. Page 506 85. Chapter 85 : Postmarket device safety monitoring - p. Page 511 86. Chapter 86 : Implementation research overview - p. Page 517 87. Chapter 87 : Design and analysis - p. Page 525 88. Chapter 88 : Mixed-methods research - p. Page 530 89. Chapter 89 : Clinical guideline development - p. Page 535 90. Chapter 90 : History of the Cooperative Group system (National Clinical Trials Network) - p. Page 542 91. Chapter 91 : Digital health - p. Page 547 92. Chapter 92 : Public health and cancer: an overview - p. Page 555 93. Chapter 93 : Epidemiology - p. Page 563 94. Chapter 94 : Multifactorial considerations of human health and public health in oncology - p. Page 572 95. Chapter 95 : Good questions - p. Page 577 96. Chapter 96 : Population and environmental-specific considerations - p. Page 584 97. Chapter 97 : Public health law - p. Page 588 98. Chapter 98 : Public health institutions and systems - p. Page 595 99. Chapter 99 : Diversity, equity, and inclusion - p. Page 600 100. Chapter 100 : Ethics in scientific publishing - p. Page 609 101. Chapter 101 : Presenting data - p. Page 618 102. Chapter 102 : Manuscript preparation - p. Page 627 103. Chapter 103 : Promoting research - p. Page 632 104. Chapter 104 : Social media and clinical trials - p. Page 636 105. Chapter 105 : Quality improvement - p. Page 638 106. Chapter 106 : Education to translate research into practice - p. Page 644 107. Chapter 107 : Team science and building a team - p. Page 652 108. Chapter 108 : Promoting research: why, how, indices h-index, m-index, etc - p. Page 656 109. Chapter 109 : Venture Pathways for aspiring radiation oncologists - p. Page 658 110. Chapter 110 : Developing Translational Ventures with the Federal Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Seed Funds - p. Page 667 111. Chapter 111 : Sample forms and templates - p. Page 672 112. Glossary - p. Page 679 113. Index - p. Page 679
