Subjects

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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 2019 to 2019
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
Language:	Czech
Teaching methods:	full-time
Level:
For type:	Master's (post-Bachelor)
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 Schedule

This subject contains the following additional online materials

E-learning course

Annotation -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

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 trend not covered by other courses. These trends include gene and cell therapies and new approaches in regenerative and transplantation medicine. The course will include invited talks from industry experts involved in clinical trials.

Aim of the course -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

Students will be able to:

Interpret results of pre-clinical and clinical studies

Familiarize with new therapeutic trends (gene and cell therapies, regenerative and transplantation medicine)

Literature -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (10.08.2022)

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)

Learning resources -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

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

Requirements to the exam -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

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

Syllabus -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

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. Gene therapies - history, targets, strategies, vectors

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

9. Epigenetics - human genome and epigenome, regulations

10. Epigenetics - current marketed drugs, their mechanism and newly developed compounds

11. Regenerative medicine

12. Cell transplantation and xenotransplantion

13. Invited talk - Practical aspects in clinical trials of new drugs

14. Invited talk - Clinical trials in the Czech Republic and the world

Registration requirements -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

none

Course completion requirements -

Last update: Spiwok Vojtěch prof. Ing. Ph.D. (18.01.2018)

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

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
		3 / 3	84 / 84

Coursework assessment
Form	Significance
Regular attendance	20
Examination test	40
Oral examination	40