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.
Key Features
- 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
INTRODUCTION 1. Introduction2. Translational Process3. Scientific Method4. Basic Research
PRE-CLINCIAL: DISCOVERY & DEVELOPMENT 5. Overview of Preclinical Research6. What problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device Discovery and Prototyping11. Device Testing12. Diagnostic Discovery13. Diagnostic Testing14. Procedural Technique Development15. Behavioral Intervention16. 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 them19. Study population: Who and why them?20. Outcome measurements: What data is being collected and why?21. Optimizing the Question: Balancing Significance and Feasibility22. Statistical Efficiency in Study Design
STATISTICAL PRINCIPLES 23. Basic statistical principles24. Distributions25. Hypotheses and error types26. Power27. Regression28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel30. Analysis of variance31. Correlation32. Biases33. Basic science statistics34. Sample Size35. Statistical Software
CLINICAL: STUDY TYPES 36. Design principles: Hierarchy of study types37. Case series: Design, measures, classic example38. Case-control study: Design, measures, classic example39. Cohort study: Design, measures, classic example40. Cross-section study: Design, measures, classic example41. Longitudinal Study: Design, Measures, Classic Example42. Meta-analysis: Design, measures, real-world examples43. Cost-effectiveness study: Design, measures, classic example44. Diagnostic test evaluation: Design, measures, classic example 45. Reliability study: Design, measures, classic example46. Database studies47. Surveys and questionnaires: Design, measures, classic example48. Qualitative methods and mixed methods49. Visual analytics: design, measures, classic example
CLINICAL TRIALS 50. Randomized control: Design, measures, classic example51. Nonrandomized control: Design, measures, classic example52. Historical control: Design, measures, classic example53. Cross-over: Design, measures, classic example54. Factorial design: Design, measures, classic example55. Large, pragmatic: Design, measures, classic example56. Equivalence and noninferiority: Design, measures, classic example57. Adaptive: Design, measures, classic example58. Randomization: Fixed or adaptive procedures59. Blinding: Who and how?60. Multicenter considerations61. Phase 0 Trials: Window of Opportunity62. Registries63. Phases of Clinical Trials64. IDEAL Framework
CLINICAL: PREPARATION 65. Patient Perspectives66. Ethics and review boards67. Regulatory considerations for new drugs and devices68. Funding approaches69. Conflicts of Interest70. Subject recruitment71. Data management72. Quality control73. Special Populations74. Report Forms: Harm and Quality of Life 75. Subject adherence76. Survival analysis
REGULATORY BASICS 77. FDA overview78. IND79. New drug application80. Devices81. Radiation-Emitting Electronic Products82. Orphan Drugs83. Biologics84. Combination Products85. CMC and GxP86. Post-Market Drug Safety Monitoring87. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION 88. Implementation Research89. Design and Analysis90. Mixed-Methods Research91. Guideline Development92. Cooperative Group Research93. Digital Health
PUBLIC HEALTH 94. Public Health95. Epidemiology96. Factors97. Good Questions98. Population- and Environmental-Specific Considerations99. Law, Policy, and Ethics100. Public Health Institutions and Systems101. DEI (Diversity, equity, inclusion)
PRACTICAL RESOURCES102. Ethics in Scientific Publishing103. Presenting Data104. Manuscript Preparation105. Promoting Research106. Social Media107. Quality Improvement108. Education to translate research into practice109. Team Science and Building a Team110. Patent Basics111. Venture Pathways112. SBIR/STTR113. Sample Forms and Templates
Oliveira, Reis & Pina