Introduction to Clinical Trials WMCM-LE-ICT-fak
This 10-session course is open to anyone interested in the process of bringing new treatment methods into medical practice. It offers a comprehensive overview of clinical trials, covering key topics such as the rationale behind conducting clinical research, different types of trials, and the characteristics of each phase. Participants will also explore the specific roles of individuals involved in the process, as well as the essential documents required at each stage. Additionally, the course will address important statistical aspects of study design, such as estimation of sample size, randomization, and blinding, along with ethical considerations. The course will also cover the application of precision medicine concepts in clinical trials design. All materials provided will be in English.
Course Outline
1. History of Clinical Trials
2. Ethical Considerations and Good Clinical Practice
3. Phases of Clinical Trials
4. Clinical Study Protocol Development
5. Categories of Research Questions
6. Study Population and Validity
7. Internal and External Validity
8. Introduction to Statistical Inference
9. Survival Analysis
Grupa przedmiotów ogólnouczenianych
Poziom przedmiotu
Symbol/Symbole kierunkowe efektów uczenia się
Typ przedmiotu
Wymagania wstępne
Koordynatorzy przedmiotu
Kryteria oceniania
To receive a grade of 5 for the course, students must actively participate in classes or complete homework assignments. If these conditions are not met, the final grade will be discussed on an individual basis.
Literatura
Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David
M. Reboussin, Christopher B. Granger, Fundamentals of Clinical
Trials, Springer Nature Switzerland AG 2015
Więcej informacji
Dodatkowe informacje (np. o kalendarzu rejestracji, prowadzących zajęcia, lokalizacji i terminach zajęć) mogą być dostępne w serwisie USOSweb: