Clinical Research — Study Design

Research Methodology · Clinical Bases

How it begins

Una revisión detallada y sistemática de los diseños de investigación en medicina. Desde la formulación de hipótesis operativas bajo el marco PICO y las bases de la causalidad, hasta el desarrollo de ensayos clínicos adaptativos, el control multivariable de factores de confusión, y la bioestadística rigurosa para la determinación del tamaño muestral.

What it covers

1. Clinical Research Methodology
2. · The Scientific Method applied to Medicine
3. · Historical Evolution and Ethical Declarations
4. Taxonomic Classification of Study Designs
5. · Methodological Classification Criteria
6. · The Pyramid of Scientific Evidence and its Reevaluation
7. Descriptive Studies I: Report and Series of Cases
8. · Report Methodology and Series of Cases
9. · Scientific Value and Hypothesis Generation
10. Descriptive Studies II: Ecological and Transversal
11. · Ecological or Conglomerate Studies
12. · Cross-sectional or Prevalence Studies (Cross-sectional)
13. Case and Control Studies
14. · Structural Design of Cases and Controls
15. · The Measure of Association: Odds Ratio (OR)
16. · Design Characteristic Biases
17. Cohort Studies
18. · Structure and Typologies of Cohort Design
19. · Association and Effect Measurement Metrics
20. · Bias Control in Cohorts
21. Randomized Clinical Trials (RCT) I: Fundamentals
22. · Randomization: The Pillar of Causality
23. · Masking or Blinding (Blinding)
24. Randomized Clinical Trials II: Advanced Designs
25. · Crossover Design
26. · Factorial Design (Therapeutic Association Structures)
27. · Non-Inferiority and Equivalence Tests
28. Randomized Clinical Trials III: Data Analysis
29. · Intention to Treat (ITT) Analysis vs. By Protocol (PP)
30. · Intermediate Analysis and Early Stop Rules
31. Bias in Clinical Research: Detection and Control
32. · Bias Classification System
33. · Confusion Control Strategies
34. Validity of Diagnostic and Prognostic Tests
35. · Classic Diagnostic Performance Metrics
36. · Likelihood Ratios
37. · ROC (Receiver Operating Characteristic) and AUC curves
38. Systematic Reviews and Meta-Analysis
39. · Systematic Review Methodology
40. · Statistical Foundations of Meta-analysis
41. · Assessment of Heterogeneity and Publication Bias
42. Phases of the Development of Drugs and Medical Devices
43. · The Four Clinical Phases of Pharmaceutical Research
44. Biostatistics and Sample Size Determination
45. · Key Concepts of Hypothesis Testing Theory
46. · Sample Size Calculation: Required Variables
47. · Introduction to Survival Analysis