Clinical Research: Introduction and Fundamentals

Research Methodology · Clinical Bases

How it begins

Un análisis exhaustivo de los pilares que sustentan la evidencia biomédica: desde la epistemología metodológica y los diseños de estudio hasta las complejidades bioestadísticas, regulaciones internacionales, bioética y medicina traslacional.

What it covers

1. Epistemology and Evolution of Clinical Research
2. · 1.1 Historical Evolution of the Method and Evidence
3. · 1.2 The Scientific Method Applied to Biomedicine
4. · 1.3 The Classical Hierarchy of Evidence
5. Taxonomy and Methodological Architecture of Study Designs
6. · 2.1 Observational Studies: Descriptive and Analytical
7. · 2.2 Experimental and Quasi-experimental Studies
8. · 2.3 Common Methodological Biases in Clinical Research
9. The Randomized Controlled Clinical Trial (RCT)
10. · 3.1 Randomization and Masking
11. · 3.2 Analysis by Intention to Treat (ITT) vs. By Protocol (PP)
12. Phases of the Clinical Development of New Drugs and Devices
13. · 4.1 Preclinical Phases and Translational Research
14. · 4.2 The Clinical Pathway: From Phase I to Phase IV
15. Biostatistics and Protocol Design
16. · 5.1 Formulation of Hypotheses and Statistical Errors
17. · 5.2 Mathematical Determination of Sample Size
18. · 5.3 Survival Analysis and Data Modeling
19. Bioethics and International Regulatory Frameworks
20. · 6.1 Ethical Milestones and the Declaration of Helsinki
21. · 6.2 Standards of Good Clinical Practice (ICH-GCP)
22. · 6.3 Ethics and Research Committees for New Drugs
23. Data Management and Pharmacovigilance
24. · 7.1 Research Data Management: CRF and eCRF
25. · 7.2 Subject Safety: Adverse Events and Pharmacovigilance
26. Translational Medicine and Biomarkers in Modern Trials
27. · 8.1 The Role of Biomarkers in Precision Research
28. · 8.2 Modern Adaptive Designs and Platform-Based Research
29. Scientific Writing, Transparency and Protocol Registration
30. · 9.1 The International Scientific Reporting Guidelines
31. · 9.2 The Mandatory Public Registry of Clinical Trials
32. Special Populations and Cutting-Edge Research
33. · 10.1 Pediatrics, Geriatrics and Pregnant Women: Scientific and Ethical Challenges
34. · 10.2 Rare Diseases and Orphan Drugs
35. Future Perspectives and Modern Methodological Challenges
36. · 11.1 Real World Evidence (RWE) and Real World Data (RWD)
37. · 11.2 Artificial Intelligence and Decentralized Testing (DCTs)