New trends in clinical research and development - M320030
Title: Nové trendy klinického výzkumu a vývoje léčiv
Guaranteed by: Department of Biochemistry and Microbiology (320)
Faculty: Faculty of Food and Biochemical Technology
Actual: from 2023
Semester: summer
Points: summer s.:3
E-Credits: summer s.:3
Examination process: summer s.:
Hours per week, examination: summer s.:2/0, Ex [HT]
Capacity: unlimited / unknown (unknown)
Min. number of students: unlimited
Qualifications:  
State of the course: taught
Language: Czech
Teaching methods: full-time
Level:  
Additional information: https://web.vscht.cz/~spiwokv/clinic/
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Fusek Martin prof. Ing. CSc.
Spiwok Vojtěch prof. Ing. Ph.D.
Benešová Eva Ing. Ph.D.
Examination dates   
This subject contains the following additional online materials
Annotation -
The aim of this course is to introduce students to organization of pre-clinical research, clinical trials (design, blinding, analysis, reporting, legislation and ethics), as well as with new therapeutic trends (e.g. personalized medicine, gene therpies, RNA based drugs, drugs targeted at epigenetic modifications etc.) not covered by other courses.
Last update: Benešová Eva (16.09.2023)
Course completion requirements -

The course will be finished by a written and oral exam. There are no prerequisites for registration to the exam.

Last update: Spiwok Vojtěch (18.01.2018)
Literature -

Z: Brody Z. Clinical Trials - Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Elsevier Amsterdam, 2012, ISBN: 978-0-12-391911-3 (Available online via National Library of Technology)

Z: Svobodník A., Demlová R., Pecen L. at al. Klinické studie v praxi, ISBN 978-80-904731-8-8, Facta Medica, 2014, Brno (in Czech, available online via https://www.czecrin.cz)

D: Středa L., Hána K. eHealth a telemedicína, Učebnice pro vysoké školy. Grada Publishing, a.s., 2016. ISBN 978-80-247-5764-3.

Last update: Benešová Eva (16.09.2023)
Requirements to the exam -

Předmět bude zakončen písemnou a ústní zkouškou. Pro zápis na zkoušku nejsou žádné podmínky.

Last update: Spiwok Vojtěch (18.01.2018)
Syllabus -

1. Pre-clinical studies

2. Design of clinical trials, randomization and blinding

3. Outcomes of clinical trials, superiority or equivalence testing

4. Clinical trial statistics and reporting (CONSORT)

5. Ethics of clinical studies, specificities of testing of new drugs, generics and biosimilars

6. Legislation A to Z - FDA, EMA, SÚKL

7. Personalized/precizion medicine

8. Biomarkers

9. Gene therapies - history, targets, strategies, vectors

10. Gene therapies - examples, ethics (help vs benefit vs damage)

11. Epigenetics - human genome and epigenome, regulations, currently marketed drugs and their mechanism of action

12. Nucleic acid based therapies

13. CRISPR-Cas

14. Invited talk

Last update: Benešová Eva (15.09.2023)
Learning resources -

https://web.vscht.cz/~spiwokv/clinic/

Lectures in electronic form published at e-learning.vscht.cz

Dictionary of Biomedicines and Fundamentals of Human Pathology available at e-learning.vscht.cz

Last update: Benešová Eva (16.09.2023)
Learning outcomes -

Students will be able to:

Interpret results of pre-clinical and clinical studies

Familiarize with new therapeutic trends

Last update: Benešová Eva (16.09.2023)
Registration requirements -

none

Last update: Spiwok Vojtěch (18.01.2018)
Teaching methods
Activity Credits Hours
Konzultace s vyučujícími 0.5 14
Účast na přednáškách 1 28
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 0.5 14
Příprava na zkoušku a její absolvování 1 28
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