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Original scientific paper

https://doi.org/10.11613/BM.2017.027

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials

Ivana Šolić ; Medical student, University of Split School of Medicine, Split, Croatia
Ana Stipčić ; Department of Health Studies, University of Split, Split, Croatia
Ivančica Pavličević ; Department of Family Medicine, University of Split School of Medicine, Split, Croatia
Ana Marušić orcid id orcid.org/0000-0001-6272-0917 ; Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia


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Abstract

IntroductionDespite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. Materials and methodsWe assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients’ associations. ResultsDespite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. ConclusionsOur study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Keywords

access to information; awareness; patient participation; clinical trials; registries

Hrčak ID:

183376

URI

https://hrcak.srce.hr/183376

Publication date:

15.6.2017.

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