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Clinical trials in Croatia and the Central Ethics Committee

A clinical trial is an experimental process of testing a new medicine or medical device on human subjects. Clinical trials will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the requirements of these Regulations. Clinical trials in Croatia are run in accordance with local laws (Drug law, and specific acts), which are in accordance with European legislation, and in some parts also in the process of current harmonization. For final regulatory approval given by the Ministry of health, it is of the utmost importance that clinical trials have a positive, mandatory ethical approval from the Central Ethics Committee (CEC) for Clinical Drug Trials. CEC is an independent body consisted of medical and nonmedical members (13 regular and 13 deputy members). Members of CEC will have the sort of experience which will be useful in scrutinizing the ethical aspects of a research proposal. In preparing its opinion, the CEC is considering the relevance of the clinical trial and its design (evaluation of the anticipated benefits and risks), the protocol, the investigator's brochure, the suitability of the investigator and supporting staff, the quality of the facilities for the trial, the adequacy and completeness of the written information to be given, and the procedure to be followed, for the purpose of obtaining informed consent to the subjects' participation in the trial. Further, provision for indemnity or compensation in the event of injury or death attributable to the clinical trial, any insurance or indemnity to cover the liability of the investigator or sponsor, the amounts, and, where appropriate, the arrangements for rewarding or compensating investigators and subjects, etc. According to a defined procedure and discussion in 2004 (after May 01) CEC positive opinion was given to 42 clinical trials, 92 in 2005, 83 in 2006, and 44 till May 01, 2007. During the last three years 87 clinical trials per year in average have positive opinion from CEC. There is a time limit of 30 days for CEC to give an opinion. In conclusion, CEC in Croatia, as an independent body, consisted of multidisciplinary members, giving qualified ethical opinions during the last period. In the future some changes in the legislation in Croatia and the European Union will have certain impact on the ethics of clinical trials, and especially on the administrative aspects. CEC should be involved as partner in the future legal changes in the field of clinical trials.

clinical trial; ethics; legislative

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