Clinical trials in the European Union and the Czech Republic in the years 2006, 2009 and 2012
Authors:
Juraj Šesták; Věra Strnadová
Authors place of work:
Veterinární a farmaceutická univerzita Brno
; Ústav humánní farmakologie a toxikologie Farmaceutickej fakulty
Published in the journal:
Čes. slov. Farm., 2014; 63, 253-262
Category:
Original Articles
Summary
The aim of this paper is to analyze clinical trials conducted in the European Union and the Czech Republic in the years 2006, 2009 and 2012. The analysis has two main points of interest: characterization of the study population (the attention is paid to the age and gender profile of the subjects’ population as well as to the fact whether healthy volunteers and/or patients were enrolled) and clinical trials focus (the phases of clinical trials and therapeutic areas the trials were focused on). In addition, the aim of this paper is to discover possible differences between the EU and the CR and to find out if the implementation of Directive 2001/20/EC of the European Parliament and Council from 4th of April 2001 had any influence on the number of clinical trials being conducted (per therapeutic area and time).
Keywords:
clinical trials • focus • participant population • healthy volunteers • placebo
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Štítky
Pharmacy Clinical pharmacologyČlánok vyšiel v časopise
Czech and Slovak Pharmacy
2014 Číslo 6
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