Izvorni znanstveni članak
Centralized National Ethical Review of Clinical Trials in Croatia
Dinko Vitezić
; University of Rijeka School of Medicine and Rijeka University Hospital Center, Rijeka, Croatia
Maja Lovrek
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Siniša Tomić
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Sažetak
Aim To present the Croatian system of ethical review of
clinical trials and assessment outcomes of the applications
reviewed by the Croatian Central Ethics Committee.
Methods Clinical trial applications reviewed by the Croatian
Central Ethics Committee, which has the legal mandate
to review clinical trials of medicinal products and
medical devices, were retrospectively analyzed from May
2004 to the end of 2008 according to the number, research
area, and type of opinion issued. Applications from 2008
were analyzed separately according to the study phase,
participants (adult trials vs pediatric trials), and sponsor
(commercial trials vs academic trials). Data were analyzed
by descriptive statistics.
Results Since its establishment in 2004, the Croatian Central
Ethics Committee has reviewed 407 trials. The greatest
number of clinical trials was in the field of oncology
(n = 69), mental and behavioral disorders (n = 52), and endocrine,
nutritional, and metabolic diseases (n = 50). In
the initial assessment of clinical trials, 60% applications received
a conditionally positive opinion. In 28% of applications,
the opinion had to be postponed because additional
documentation or explanations were required. In 2008, the
Croatian Central Ethics Committee reviewed 99 trials, most
of which were phase III trials (n = 57). Five clinical trials included
pediatric population and 3 were academic clinical
trials.
Conclusion The model of centralized clinical trial review
seems to be appropriate for the current number of clinical
trials conducted in Croatia. The efficient and standardized
review process of clinical trials by the Central Ethics
Committee may positively affect the increasing number
of clinical trials conducted in Croatia. Future development
includes the transparency of the clinical trials through a
publically available database and establishing the basis for
conducting academic clinical trials in Croatia.
Ključne riječi
Ethics Committees; Clinical Trials; Research; Ethical Review; Centralized Ethical Procedure
Hrčak ID:
38311
URI
Datum izdavanja:
15.4.2009.
Posjeta: 1.335 *