Translational Neurosurgery

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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• Ciências da vida: temas gerais

neurosurgery; translational neurosurgery; translational research; clinical research; statistical principles; case-control study; cohort study; clinical trials; reliability study; research regulatory