Course Overview

Clinical research is a growing field and demands well prepared researchers from all _reas of health graduation courses. The complexity and variety of methods appied to clinical research, as well as the ethical issues brought by the proposition of protocols in this _rea require adequate training and background. Graduate students, both from master and PhD courses, need to enhance their knowledge and practice in the topics related to clinical research.

Learning Achievement

To present and to discuss ethical basis and main methods of clinical research based on good practice principles. At the end of the discipline, graduate students will be able to write a research protocol, to analyze their project data and to elaborate a publication in their research field.

Competence

Course prerequisites

Grading Philosophy

Being an on-line discipline, presence is evaluated by student participation in the discussion forum at least once each week, and the quality of comments posted are graded. Week assignments and a final exam at the end of the discipline compose the final grade of the student.

Course schedule

1. Ethical and bioethical principles 2. Research question 3. Clinical variables: biomarkers and surrogate endpoints 4. Statistical basis 5. Study design 6. Sampling, validity, bias, randomization and blinding 7. Advanced statistical methods 8. Sample size calculation 9. Assessment of adverse effects and medication adherence 10. Adaptative design and interim analyses 11. Propensity scores 12. Writing a protocol 13. Clinical research as a profession 14. Publishing

Course type

Online Course Requirement

Instructor

Wu Tu Hsing Raymundo Soares de Azevedo Neto

Other information

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