Translational Neurosurgery provides a comprehensive overview reflecting the depth and breadth of the field of translational research focused on neurosurgery, with input from a distinguished team of basic and clinical investigators. It covers the principles of evidence-based medicine and applies these principles to the design of translational investigations, helping researchers navigate challenging considerations in study design and implementation. This book is a valuable resource for neurosurgeons and neurosurgery investigators who want to understand more about translational research, and also…mehr
Translational Neurosurgery provides a comprehensive overview reflecting the depth and breadth of the field of translational research focused on neurosurgery, with input from a distinguished team of basic and clinical investigators. It covers the principles of evidence-based medicine and applies these principles to the design of translational investigations, helping researchers navigate challenging considerations in study design and implementation. This book is a valuable resource for neurosurgeons and neurosurgery investigators who want to understand more about translational research, and also for basic scientists interested in translating their research into clinical practice.
Section 1: Introduction 1. Translational Process 2. Scientific Method Section 2: Pre-Clinical 4. What problem are you solving? 5. Types of interventions 6. Drug testing 7. Device discovery and prototyping 8. Diagnostic testing 9. Artificial Intelligence Section 3: Statistical Principles 10. Basic statistical principles 11. Distributions 12. Hypotheses and error types 13. Power 14. Continuous variable analyses 15. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 16. Analysis of variance 17. Correlation 18. Basic science statistics 19. Sample Size 20. Statistical Software Section 4: Clinical: Study Types 21. Outcome measurements: What data is being collected and why? 22. Case series: Design, measures, classic example 23. Case-control study: Design, measures, classic example 24. Cross-section study: Design, measures, classic example 25. Longitudinal study: Design, measures, classic example 26. Meta-analysis: Design, measures, classic example 27. Qualitative methods and mixed methods Section 5: Clinical Trials 28. Randomization and Multicentric Considerations in Clinical Trials 29. Nonrandomized Control 30. Historical Control 31. Study Types with Design, Measures, Classic Example 32. Blinding: Who and How? 33. Adaptive: Design, measures, classic example 34. Phase 0 Trials: Window of Opportunity 35. Registries, Phases of Clinical Trials, IDEAL Framework Section 6: Regulatory Basics 36. FDA overview 37. IND 38. Devices 39. Radiation-emitting Electronic Products 40. Biologics 41. Combination Products 42. A Brief Overview of the FDAs Involvement in the Regulation of Dietary Supplements 43. Cosmetics 44. CMC and GxP 45. Non-US regulatory 46. Post-Market Drug Safety Monitoring 47. Post-Market Device Safety Monitoring Section 7: Public Health 48. Public Health 49. Epidemiology 50. Factors 51. Good Questions 52. Population- and Environmental-specific Considerations 53. Healthcare Institutions and Systems 54. Public Health Institutions and Systems 55. Presenting Data
Section 1: Introduction 1. Translational Process 2. Scientific Method Section 2: Pre-Clinical 4. What problem are you solving? 5. Types of interventions 6. Drug testing 7. Device discovery and prototyping 8. Diagnostic testing 9. Artificial Intelligence Section 3: Statistical Principles 10. Basic statistical principles 11. Distributions 12. Hypotheses and error types 13. Power 14. Continuous variable analyses 15. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel 16. Analysis of variance 17. Correlation 18. Basic science statistics 19. Sample Size 20. Statistical Software Section 4: Clinical: Study Types 21. Outcome measurements: What data is being collected and why? 22. Case series: Design, measures, classic example 23. Case-control study: Design, measures, classic example 24. Cross-section study: Design, measures, classic example 25. Longitudinal study: Design, measures, classic example 26. Meta-analysis: Design, measures, classic example 27. Qualitative methods and mixed methods Section 5: Clinical Trials 28. Randomization and Multicentric Considerations in Clinical Trials 29. Nonrandomized Control 30. Historical Control 31. Study Types with Design, Measures, Classic Example 32. Blinding: Who and How? 33. Adaptive: Design, measures, classic example 34. Phase 0 Trials: Window of Opportunity 35. Registries, Phases of Clinical Trials, IDEAL Framework Section 6: Regulatory Basics 36. FDA overview 37. IND 38. Devices 39. Radiation-emitting Electronic Products 40. Biologics 41. Combination Products 42. A Brief Overview of the FDAs Involvement in the Regulation of Dietary Supplements 43. Cosmetics 44. CMC and GxP 45. Non-US regulatory 46. Post-Market Drug Safety Monitoring 47. Post-Market Device Safety Monitoring Section 7: Public Health 48. Public Health 49. Epidemiology 50. Factors 51. Good Questions 52. Population- and Environmental-specific Considerations 53. Healthcare Institutions and Systems 54. Public Health Institutions and Systems 55. Presenting Data
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