Translational Radiation Oncology: Handbook for Designing and Conducting Clinical and Translational Research
Editat de Jeffrey A. Bakal, Daniel Kim, David Wazer, Adam E.M. Eltoraien Limba Engleză Paperback – 3 aug 2023
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.
- Provides a clear process for understanding, designing, executing and analyzing clinical and translational research
- Presents practical, step-by-step guidance to help readers take ideas from the lab to the bedside
- Written by a team of oncologists, radiologists and clinical research experts that fully cover translational research in radiation oncology
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Specificații
ISBN-13: 9780323884235
ISBN-10: 0323884237
Pagini: 734
Ilustrații: 150 illustrations (50 in full color)
Dimensiuni: 216 x 276 x 41 mm
Greutate: 1.98 kg
Editura: ELSEVIER SCIENCE
Seria Handbook for Designing and Conducting Clinical and Translational Research
ISBN-10: 0323884237
Pagini: 734
Ilustrații: 150 illustrations (50 in full color)
Dimensiuni: 216 x 276 x 41 mm
Greutate: 1.98 kg
Editura: ELSEVIER SCIENCE
Seria Handbook for Designing and Conducting Clinical and Translational Research
Cuprins
INTRODUCTION 1. Introduction; 2. Translational Process; 3. Scientific Method; 4. Basic Research
PRE-CLINCIAL: DISCOVERY AND DEVELOPMENT 5. Overview of Preclinical Research; 6. What problem are you Solving?; 7. Types of Interventions; 8. Drug discovery; 9. Drug Testing; 10. Device Discovery and Prototyping; 11. Device Testing; 12. Diagnostic Discovery; 13. Diagnostic Testing; 14. Procedural Technique Development; 15. Behavioral Intervention; 16. Artificial Intelligence
CLINICAL: FUNDAMENTALS 17. Introduction to clinical research: What is it? Why is it needed?; 18. The question: Types of research questions and how to develop them; 19. Study population: Who and why them?; 20. Outcome measurements: What data is being collected and why?; 21. Optimizing the Question: Balancing Significance and Feasibility; 22. Statistical Efficiency in Study Design
STATISTICAL PRINCIPLES 23. Basic statistical principles; 24. Distributions; 25. Hypotheses and error types; 26. Power; 27. Regression; 28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank; 29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel; 30. Analysis of variance; 31. Correlation; 32. Biases; 33. Basic science statistics; 34. Sample Size; 35. Statistical Software
CLINICAL: STUDY TYPES 36. Design principles: Hierarchy of study types; 37. Case series: Design, measures, classic example; 38. Case-control study: Design, measures, classic example; 39. Cohort study: Design, measures, classic example; 40. Cross-section study: Design, measures, classic example; 41. Longitudinal Study: Design, Measures, Classic Example; 42. Meta-analysis: Design, measures, real-world examples; 43. Cost-effectiveness study: Design, measures, classic example; 44. Diagnostic test evaluation: Design, measures, classic example; 45. Reliability study: Design, measures, classic example; 46. Database studies; 47. Surveys and questionnaires: Design, measures, classic example; 48. Qualitative methods and mixed methods; 49. Visual analytics: design, measures, classic example
CLINICAL TRIALS 50. Randomized control: Design, measures, classic example; 51. Nonrandomized control: Design, measures, classic example; 52. Historical control: Design, measures, classic example; 53. Cross-over: Design, measures, classic example; 54. Factorial design: Design, measures, classic example; 55. Large, pragmatic: Design, measures, classic example; 56. Equivalence and noninferiority: Design, measures, classic example; 57. Adaptive: Design, measures, classic example; 58. Randomization: Fixed or adaptive procedures; 59. Blinding: Who and how?; 60. Multicenter considerations; 61. Phase 0 Trials: Window of Opportunity; 62. Registries; 63. Phases of Clinical Trials; 64. IDEAL Framework
CLINICAL: PREPARATION 65. Patient Perspectives; 66. Ethics and review boards; 67. Regulatory considerations for new drugs and devices; 68. Funding approaches; 69. Conflicts of Interest; 70. Subject recruitment; 71. Data management; 72. Quality control; 73. Special Populations; 74. Report Forms: Harm and Quality of Life; 75. Subject adherence; 76. Survival analysis
REGULATORY BASICS 77. FDA overview; 78. IND; 79. New drug application; 80. Devices; 81. Radiation-Emitting Electronic Products; 82. Orphan Drugs; 83. Biologics; 84. Combination Products; 85. CMC and GxP; 86. Post-Market Drug Safety Monitoring; 87. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION 88. Implementation Research; 89. Design and Analysis; 90. Mixed-Methods Research; 91. Guideline Development; 92. Cooperative Group Research; 93. Digital Health
PUBLIC HEALTH 94. Public Health; 95. Epidemiology; 96. Factors; 97. Good Questions; 98. Population- and Environmental-Specific Considerations; 99. Law, Policy, and Ethics; 100. Public Health Institutions and Systems; 101. DEI (Diversity, equity, inclusion)
PRACTICAL RESOURCES102. Ethics in Scientific Publishing; 103. Presenting Data; 104. Manuscript Preparation; 105. Promoting Research; 106. Social Media; 107. Quality Improvement; 108. Education to translate research into practice; 109. Team Science and Building a Team; 110. Patent Basics; 111. Venture Pathways; 112. SBIR/STTR; 113. Sample Forms and Templates
PRE-CLINCIAL: DISCOVERY AND DEVELOPMENT 5. Overview of Preclinical Research; 6. What problem are you Solving?; 7. Types of Interventions; 8. Drug discovery; 9. Drug Testing; 10. Device Discovery and Prototyping; 11. Device Testing; 12. Diagnostic Discovery; 13. Diagnostic Testing; 14. Procedural Technique Development; 15. Behavioral Intervention; 16. Artificial Intelligence
CLINICAL: FUNDAMENTALS 17. Introduction to clinical research: What is it? Why is it needed?; 18. The question: Types of research questions and how to develop them; 19. Study population: Who and why them?; 20. Outcome measurements: What data is being collected and why?; 21. Optimizing the Question: Balancing Significance and Feasibility; 22. Statistical Efficiency in Study Design
STATISTICAL PRINCIPLES 23. Basic statistical principles; 24. Distributions; 25. Hypotheses and error types; 26. Power; 27. Regression; 28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank; 29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel; 30. Analysis of variance; 31. Correlation; 32. Biases; 33. Basic science statistics; 34. Sample Size; 35. Statistical Software
CLINICAL: STUDY TYPES 36. Design principles: Hierarchy of study types; 37. Case series: Design, measures, classic example; 38. Case-control study: Design, measures, classic example; 39. Cohort study: Design, measures, classic example; 40. Cross-section study: Design, measures, classic example; 41. Longitudinal Study: Design, Measures, Classic Example; 42. Meta-analysis: Design, measures, real-world examples; 43. Cost-effectiveness study: Design, measures, classic example; 44. Diagnostic test evaluation: Design, measures, classic example; 45. Reliability study: Design, measures, classic example; 46. Database studies; 47. Surveys and questionnaires: Design, measures, classic example; 48. Qualitative methods and mixed methods; 49. Visual analytics: design, measures, classic example
CLINICAL TRIALS 50. Randomized control: Design, measures, classic example; 51. Nonrandomized control: Design, measures, classic example; 52. Historical control: Design, measures, classic example; 53. Cross-over: Design, measures, classic example; 54. Factorial design: Design, measures, classic example; 55. Large, pragmatic: Design, measures, classic example; 56. Equivalence and noninferiority: Design, measures, classic example; 57. Adaptive: Design, measures, classic example; 58. Randomization: Fixed or adaptive procedures; 59. Blinding: Who and how?; 60. Multicenter considerations; 61. Phase 0 Trials: Window of Opportunity; 62. Registries; 63. Phases of Clinical Trials; 64. IDEAL Framework
CLINICAL: PREPARATION 65. Patient Perspectives; 66. Ethics and review boards; 67. Regulatory considerations for new drugs and devices; 68. Funding approaches; 69. Conflicts of Interest; 70. Subject recruitment; 71. Data management; 72. Quality control; 73. Special Populations; 74. Report Forms: Harm and Quality of Life; 75. Subject adherence; 76. Survival analysis
REGULATORY BASICS 77. FDA overview; 78. IND; 79. New drug application; 80. Devices; 81. Radiation-Emitting Electronic Products; 82. Orphan Drugs; 83. Biologics; 84. Combination Products; 85. CMC and GxP; 86. Post-Market Drug Safety Monitoring; 87. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION 88. Implementation Research; 89. Design and Analysis; 90. Mixed-Methods Research; 91. Guideline Development; 92. Cooperative Group Research; 93. Digital Health
PUBLIC HEALTH 94. Public Health; 95. Epidemiology; 96. Factors; 97. Good Questions; 98. Population- and Environmental-Specific Considerations; 99. Law, Policy, and Ethics; 100. Public Health Institutions and Systems; 101. DEI (Diversity, equity, inclusion)
PRACTICAL RESOURCES102. Ethics in Scientific Publishing; 103. Presenting Data; 104. Manuscript Preparation; 105. Promoting Research; 106. Social Media; 107. Quality Improvement; 108. Education to translate research into practice; 109. Team Science and Building a Team; 110. Patent Basics; 111. Venture Pathways; 112. SBIR/STTR; 113. Sample Forms and Templates