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Clinical and Noninterventional Trials Assessment in Croatia

Introduction: Clinical trials (CT) and noninterventional trials (NIT) in Croatia are conducted in accordance with local laws (Drug law, and specific acts), and CT legislation is in accordance with European legislation. The Ministry of Health gives a final regula- tory approval for CT. Since 2004, all clinical trials in Croatia have had to be reviewed by the Central Ethics Committee (CEC) and a favorable opinion must be issued before a clinical trial commences. Since December 2007, the CEC has also been responsible for issu- ing opinions on noninterventional trials. During the trial evaluation procedure, CEC assesses scientific and ethical considerations of the trial. The aim of this analysis is to present the procedure of central evaluation and statistics of the CEC. Patients (or Materials) and Methods: The database of the CEC is analyzed, and the trials are presented according to indication (topic), phase, and opinion issued after the first evaluation. Results: According to a defined procedure and discussion, the CEC positive opinion has been given to 702 CT (since May 2004– 2012). During the last 5 years, 80 CT per year on average have had a posi- tive opinion from the CEC. The greatest number of CT have been in the field of oncology (147), mental and behavioural disorders (95), and endocrine, nutritional, and metabolic diseases (88), and mostly Phase III trials. During the period of the last 5 years, CEC assessed 67 NIT. The decisions after the first evaluation were conditionally positive or postponed opinion. Conclusion: The model of centralized CT assessment through the Central Ethics Committee, as an independent body, has been con- firmed during the investigated period as appropriate for Croatia. Furthermore, CEC assessment of NIT has also been confirmed as useful because this procedure, as a gatekeeper, prevents conducting the trials only for marketing purposes and allows in Croatia only NIT of certain quality and scientific merit.

clinical trials; non-interventinal trials; assessment; economic impact

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