Clinical Research — Study Design

Research Methodology · Clinical Bases

How it begins

A detailed and systematic review of research designs in medicine. From the formulation of operational hypotheses under the PICO framework and the bases of causality, to the development of adaptive clinical trials, multivariate control of confounding factors, and rigorous biostatistics for determining sample size.

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
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