title: Centralized national ethical review of clinical trials in Croatia.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Rijeka School of Medicine, Brace Branchetta 20, 51000 Rijeka, Croatia. vdinko@medri.hr
authors.forename: Dinko
authors.initials: D
authors.lastname: Vitezić
authors.forename: Maja
authors.initials: M
authors.lastname: Lovrek
authors.forename: Sinisa
authors.initials: S
authors.lastname: Tomić
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000706:statistics & numerical data*; D017523:Croatia; D026724:Ethical Review / Q000592:standards*; D017041:Ethics Committees / Q000458:organization & administration*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D009313:National Health Programs / Q000458:organization & administration; D009937:Organizational Objectives; D011050:Policy Making; D015397:Program Evaluation