TRANSLATIONAL INTERVENTIONAL RADIOLOGY

INTRODUCTION
1. Translational Process; 2. Scientific Method; 3. Basic research

PRE-CLINICAL: DISCOVERY AND DEVELOPMENT
4. Overview of preclinical research; 5. Defining the problem to solve; 6. Types of problems; 7. Types of Interventions; 8. Drug discovery; 9. Drug safety; 10. Device discovery; 11. Device prototyping; 12. Device classification; 13. Device testing; 14. Diagnostic testing; 15. Other product types; 16. Procedural technique development; 17. Behavioral intervention

CLINICAL: FUNDAMENTALS
18. Introduction to clinical research: What is it? Why is it needed?; 19. The question: Types of research questions and how to develop them; 20. Study population: Who and why them?; 21. Outcome measurements: What data is being collected and why?; 22. Optimizing the question: Balancing significance and feasibility

STATISTICAL PRINCIPLES
23. Common issues in analysis; 24. Basic statistical principles; 25. Distributions; 26. Hypotheses and error types; 27. Power; 28. Regression; 29. t-test; 30. Chi-square; 31. Analysis of variance; 32. Correlation; 33. Biases; 34. Basic science statistics

CLINICAL: STUDY TYPES
35. Design principles: Hierarchy of study types; 36. Case series: Design, measures, classic example; 37. Case-control study: Design, measures, classic example; 38. Cohort study: Design, measures, classic example; 39. Cross-section study: Design, measures, classic example; 40. Longitudinal study: Design, measures, classic example; 41. Clinical trials: Design, measures, classic example; 42. Meta-analysis: Design, measures, classic example; 43. Cost-effectiveness analysis: Design, measures, classic example; 44. Diagnostic test evaluation: Design, measures, classic example; 45. Reliability study: Design, measures, classic example; 46. Surveys and questionnaires: Design, measures, classic example; 47. Qualitative methods and mixed methods

CLINICAL TRIALS
48. Randomized control: Design, measures, classic example; 49. Nonrandomized control: Design, measures, classic example; 50. Historical control: Design, measures, classic example; 51. Cross-over: Design, measures, classic example; 52. Withdrawal studies: Design, measures, classic example; 53. Factorial design: Design, measures, classic example; 54. Group allocation: 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. Registries; 62. Phases of clinical trials; 63. IDEAL Framework; 64. Artificial Intelligence; 65. Patient perspectives

CLINICAL: PREPARATION
66. Meaningful outcome measurements; 67. Sample size; 68. Budgeting; 69. Ethics and review boards; 70. Regulatory considerations for new drugs and devices; 71. Funding approaches; 72. Subject recruitment; 73. Data management; 74. Quality control; 75. Statistical software; 76. Report forms: Harm and Quality of Life; 77. Subject adherence; 78. Monitoring committee in clinical trials

REGULATORY
79. FDA overview; 80. IND; 81. New drug application; 82. Device pathways; 83. Radiation-emitting electronic products; 84. Combination products; 85. Cosmetics; 86. CMC and GxP; 87. Non-US regulatory; 88. Post-Market Drug Safety Monitoring; 89. Post-Market Device Safety Monitoring

CLINICAL IMPLEMENTATION
90. Implementation Research; 91. Design and analysis; 92. Mixed-methods research; 93. Population- and setting-specific implementation

PUBLIC HEALTH
94. Public Health; 95. Epidemiology; 96. Good questions; 97. Population- and environmental-specific considerations; 98. Law, policy, and ethics; 99. Healthcare institutions and systems; 100. Public health institutions and systems

• Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within interventional radiology
• Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation
• Details discussions of the critical appraisal of published studies in interventional radiology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care

Authors
• Adam E.M. Eltorai, Brown University Warren Alpert Medical School, Marlborough, MA, USA.
• Tao Liu, Associate Professor of Biostatistics and?Director of the Brown ARCH Data and Statistics Core, Brown University, USA.
• Rajat Chand, Early Specialization in Interventional Radiology (ESIR) Resident, John H. Stroger, Jr. Hospital of Cook County Chicago, IL, USA.
• Sanjeeva P. Kalva, Assistant Professor of Radiology, Massachusetts General Hospital, Boston, Massachusettes, USA