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Epidemiology and Clinical Development of New Drugs
Cursusdoel
- Recognize the research cycle and the role of clinical trials and observational studies in drug development and testing
- Design and execute the collection of experimental data
- Design a randomized clinical trial to answer a real-world question about drug efficacy and safety
- Use standard statistical methods and software to analyse data from a clinical trial
- Understand the ethical issues related to drug development and testing
- Search for, manage and critically evaluate scientific literature
- Write a research report, design a scientific poster and present scientific results
- Execute basic group work and meeting skills
Vakinhoudelijk
The clinical process, however, cannot guarantee that all adverse effects are identified and the drug will work as well as expected in practice. Therefore, epidemiologic research and post-marketing studies are necessary. In this course you will learn about how the safety and efficacy of pharmaceutical products is researched in human populations. You will learn the basics of statistics and epidemiology used when designing and analysing clinical studies. In addition, you will develop key research skills so that you can navigate sources of scientific information and critically appraise the validity of scientific literature.
Werkvormen
Hoorcollege
Werkcollege
Toetsing
Eindresultaat
Verplicht | Weging 100% | ECTS 15
The grade is based on four assessments: a clinical trails group project (30% overall; 70% written report & 20% oral presentation), a pharmacoepidemiology group project ( 20% overall; 70% written report & 20% oral presentation) and a grade for an individual exam on statistics and epidemiology (50%).
Ingangseisen en voorkennis
Ingangseisen
Er is geen informatie over verplichte ingangseisen bekend.
Voorkennis
Er is geen informatie over benodigde voorkennis bekend.
Voertalen
- Engels
Cursusmomenten
Gerelateerde studies
Tentamens
Er is geen tentamenrooster beschikbaar voor deze cursus
Verplicht materiaal
Materiaal | Omschrijving |
---|---|
BOEK | Medical statistics at a glance. ISBN 9781405180511 Petrie, A. | Blackwell Scientific Publ | Druk: 3 |
SOFTWARE | IBM SPSS (surfspot.nl/spss) |
Aanbevolen materiaal
Materiaal | Omschrijving |
---|---|
BOEK | Drug discovery and development technology in transition. ISBN 9780702042997 Hill, R. | Bailliere Tindall | Druk: 3 |
BOEK | Spiegelhalter, D. (2019). The Art of Statistics: How to Learn from Data. |
BOEK | Rothman, K. J. (2012). Epidemiology: An Introduction. |
Coördinator
dr. D.L. Weir | d.l.weir@uu.nl |
Docenten
Inschrijving
Inschrijving
Van dinsdag 30 mei 2023 tot en met vrijdag 23 juni 2023
Inschrijving niet geopend
Permanente link naar de cursuspagina
Laat in de Cursus-Catalogus zien