MVV309K Clinical Trials

Faculty of Law
Spring 2020
Extent and Intensity
0/1/0. 3 credit(s). Type of Completion: k (colloquium).
Teacher(s)
Katarzyna Syroka-Marczewska, Ph.D. (seminar tutor), prof. JUDr. Ing. Michal Radvan, Ph.D. (deputy)
Guaranteed by
prof. JUDr. Ing. Michal Radvan, Ph.D.
Faculty of Law
Contact Person: Mgr. Věra Redrupová, B.A.
Supplier department: Faculty of Law
Timetable of Seminar Groups
MVV309K/01: No timetable has been entered into IS.
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.

The capacity limit for the course is 30 student(s).
Current registration and enrolment status: enrolled: 0/30, only registered: 0/30
fields of study / plans the course is directly associated with
there are 38 fields of study the course is directly associated with, display
Course objectives
The course will explore the issue of clinical trials which is becoming increasingly popular alongside the development of medical sciences. The trials are conducted simultaneously in various countries and for this very reason these are very complex processes from the organisational perspective. The patients who are to take part in the trials are selected from among persons residing in locations where the medicine will be available after registration. As a result it may be quite precisely established how effective and safe a given particle is in various populations. This is why all clinical trials are conducted in accordance with a uniform medical, ethical and scientific standard laid down in the principles of Good Clinical Practice.
The subject matter of the corse is an analysis of the provisions of the legal regulation concerning clinical trials. The general principle governing clinical trials is patient’s welfare which should override the interest of science and society, but how it looks like in practice. Another rule constituting a prerequisite of lawful clinical trials in UE is the patient’s consent, but what kind of legal problems it could create. Furthermore, clinical trials are conducted in four phases (stages). Each phase needs to end with a positive result in order to be able to move on to the next one. First, the safety of a given active substance is preliminarily assessed together with its metabolism, absorption, excretion, possible toxicity, and interactions with other substances used by the patient. Following that, it is possible to determine the dosage of the substance tested The second phase aims at determining whether the medicine brings results in a group of patients and whether it is safe for them. At this stage, the effects of the new medicine and placebo or the medicine used in the treatment of a given disease, are compared. The comparison is performed with the use of the blind study method, which is supposed to ensure the most objective evaluation of the effects possible .The next phase is the trial conducted in numerous groups of participants with a view to determining the safety and therapeutic efficacy of the new medicinal product in relation to a particular disease and, where possible, with the employment of double-blind study method and random selection of participants (randomisation). Such trial is intended to enable the determination of the incidence of occurrence of the most frequent adverse effects and factors modifying the potency of action of the product . After successful completion of phase three of the clinical trials, the medicine may be registered and marketed. Once a medicinal product in marketed, its safety and efficacy continue to be monitored. The final phase of the clinical trials concerns medicines which are already marketed and its objective is to verify whether the medicine is safe in all indications given by the producer and for all groups of patients. In the course of this phase, the results of the previous phases are additionally verified. Pharmacovigilance consist, above all, in collecting and analysing information on adverse effects.
As a consequence of rapid progress of medical sciences, the legislators are confronted with the need to adapt the existing legal frames to new challenges posed by contemporary medical procedures. In my opinion it concerns European Union and another countries.
Learning outcomes
At the end of the course, students should be able to:
- understand and explain the characteristics of the European legal system within the clinical trials field
- interpret the basic principles of European legislation
- correctly analyze EU Court of Justice case-law on medical products.
Syllabus
  • 1. Pharmaceutical law- introduction
  • 2. Rules for conducting clinical trials
  • 3. Clinical trials phases
  • 4. Good Clinical Practice
  • 5. The rules and procedure for authorising medicinal products for marketing
Literature
  • Friedman Lawrence M., Fundamentals of Clinical Trials, 2015
Teaching methods
Lectures and discussion
Assessment methods
One short paper (max 4 - 5 pages)
Language of instruction
English
Further Comments
Study Materials
The course is taught only once.
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