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Epidemiology and Clinical Development of New Drugs (2025/2026: Periode 1)
Cursusdoel
After this course you will be able to:
- 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
We all know people who use medication, for example to treat chronic diseases, infections or just simple headaches. How do we know that they work? How do we know that they are safe? Currently there are many drugs on the market for multiple diseases. They could only enter the market after their efficacy and safety were thoroughly investigated in clinical trials, first in human volunteers (phase I) and later on in groups of patients (phase II and III). The creation of a new drug can broadly be divided into three main stages: Drug Discovery, Drug Development, and the Commercialization of the drug. These phases together are often referred to as the ‘Drug Pipeline’.
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.
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.
Aanvullende informatie
CPS courses contain Honors elements that provide academic depth and breadth to students. Depending on the course, this means that you take in extra information, complete special assignments or work intensively on your academic skills. It often involves a combination of these elements. Teachers expect greater independence, challenge you and, where possible, give you freedom of choice in the topics you work on and the way you complete the assignments. The group assignments focus on the application, creation and integration of knowledge.
Werkvormen
Groepsonderwijs
Hoorcollege
Werkcollege
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
-
BOEKMedical statistics at a glance. ISBN 9781405180511 Petrie, A. | Blackwell Scientific Publ | Druk: 3
-
SOFTWAREIBM SPSS (surfspot.nl/spss)
Aanbevolen materiaal
-
BOEKDrug discovery and development technology in transition. ISBN 9780702042997 Hill, R. | Bailliere Tindall | Druk: 3
-
BOEKSpiegelhalter, D. (2019). The Art of Statistics: How to Learn from Data.
-
BOEKRothman, K. J. (2012). Epidemiology: An Introduction.
Coördinator
| dr. D.L. Weir | d.l.weir@uu.nl |
Docenten
Inschrijving
Let op: deze cursus is niet toegankelijk voor studenten van andere faculteiten, bijvakkers mogen zich dus niet inschrijven.
Inschrijving
Van maandag 2 juni 2025 tot en met vrijdag 20 juni 2025
Naar OSIRIS-inschrijvingen
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