The role of clinical trials in science and clinical practice course

Welcome to the e-learning course entitled Clinical Research!

This course focuses on the theoretical basis for understanding Clinical Research. The course aims to acquaint the student with the advantages and disadvantages of this research modality, how to ask and answer the appropriate clinical question, and the approach to reading critical literature. Topics embrace the entire process, divided into two main parts: clinical research planning and maintenance&closure. The first part will introduce you to the aim of clinical research, study types, sources of bias, hypotheses, statistical and ethical considerations, IT background, data protection, and the role of contributors. The second section includes presentations on patient enrollment, quality control, analysis, and article writing.

Lectures:

Part I.: Clinical research planning phase

1. The purpose of clinical research
2. Clinical research types
3. Observational studies
4. Descriptive studies
5. Analytical studies: cohort, case-control and cross-sectional studies
6. Bias in observational studies
7. Experimental studies
8. Hypotheses in randomized controlled trials
9. Randomized controlled trials: phases and designs
10. Bias in randomized controlled trials
11. Reduction of bias in experimental studies: masking and blinding
12. Randomization types
13. Interventions and outcomes of clinical trials
14. Statistical considerations: sample size calculation
15. Statistical considerations: multiplicity
16. Statistical considerations: group sequential trials
17. Statistical considerations: missing data
18. Statistical considerations: adaptive clinical trials
19. Clinical trial regulations
20. Data protection in clinical research
21. Introduction of the Clinical Trial Coordinator Group
22. Preparation of the pre-study protocol
23. Ethical approvals
24. Data collection and quality
25. Biobank sample collection
26. IT development
27. Human and financial resources (PI, CRA)

Part II: II. Clinical Research Running phase and Closure

28. Patient enrollment
29. Maintaining a study, quality assurance
30. Closure of a clinical study, interim analysis
31. Data structure
32. Data types, scales
33. Descriptive statistics
34. Comparative statistics
35. Level of evidence
36. Article structure of randomized controlled trials
37. Authorship policy
38. Distribution of your findings