From clinical trials to big data research

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Faculteit Science and Engineering
Jaar 2022/23
Vakcode WBFA050-05
Vaknaam From clinical trials to big data research
Niveau(s) bachelor
Voertaal Engels
Periode semester II a
ECTS 5
Rooster rooster.rug.nl

Uitgebreide vaknaam From clinical trials to big data research
Leerdoelen At the end of the course, the student is able to:
1. distinguish different pharmacoepidemiological study types, designs, and research questions.
2. distinguish the different phases of pre-registration clinical drug research.
3. discuss considerations relevant for drug regulatory decision-making and recognize opportunities for real-world data to support in this.
4. describe the concept of post-registration drug safety monitoring and recognize statistical methods for signal detection using spontaneous reporting databases (pharmacovigilance).
5. describe post-registration studies on drug prescribing, dispensing, and taking (drug utility).
6. describe the concept of personalized medicine and recognize opportunities for omics technologies to support in this.
7. recognize challenges associated with real-world data management and apply statistical approaches that allow for making more valid interpretations and inferences from those data.
8. select the appropriate study design for a clinical drug trial and formulate a corresponding CCMO trial protocol summary.
Omschrijving This course addresses key concepts within clinical drug research ranging from pre-registration clinical trials to regulatory decision-making, post-registration research on drug use and safety, and the use of omics technologies in further personalization of pharmacotherapeutic treatments. Students will acquire knowledge from different perspectives including that of commercial, academic, and governmental parties. The course subjects are dealt with during lectures which are complemented with practical work on managing clinical data (SQL), tutorials on interpreting clinical data, and an assignment in which students will develop ideas for a next phase drug trial and subsequently draft and present a synopsis report for such a trial (CCMO).
Uren per week
Onderwijsvorm Hoorcollege (LC), Opdracht (ASM), Practisch werk (PRC), Werkcollege (T)
(Lecture 24hrs Tutorial 8 hrs Interaction/subgroup effects Assignment 48 hrs CCMO trial protocol summary Practical 24 hrs. SQL questions)
Toetsvorm Presentatie (P), Schriftelijk tentamen (WE), Verslag (R)
(The total mark is based on a written exam (50%), a report (25%), and a presentation (25%), and the marks of all parts need to be higher than 5.5. Presence during the tutorials is mandatory, and the SQL questions as part of the practical work need to be completed before a final mark will be given.)
Vaksoort bachelor
Coördinator dr. F. Klont
Docent(en) dr. S. de Vos ,prof. dr. E. Hak ,dr. F. Klont ,prof. dr. E.P. van Puijenbroek
Entreevoorwaarden
Opmerkingen
Opgenomen in
Opleiding Jaar Periode Type
BSc Farmacie  (hoofdprogramma) 3 semester II a keuzegroep