Šolić Ivana, Stipčić Ana, Pavličević Ivančica, Marušić Ana
Medical student, University of Split School of Medicine, Split, Croatia.
Department of Health Studies, University of Split, Split, Croatia.
Biochem Med (Zagreb). 2017 Jun 15;27(2):259-269. doi: 10.11613/BM.2017.027.
Despite 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.
We 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.
Despite 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.
Our 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.
尽管通过国际试验注册机构临床试验的可见度有所提高，但患者往往仍不了解其存在，特别是如果他们无法获取有关临床研究的充分信息，包括信息的语言。本研究的目的是描述克罗地亚临床试验透明度相对于中欧和东欧国家的背景情况，并评估克罗地亚患者对临床试验及其可及性的了解程度。
我们根据公开领域可得的数据评估了临床试验的透明度。我们还对克罗地亚南部两家家庭医疗诊所或肿瘤科的257名就诊患者以及全国患者协会成员组成的便利样本进行了匿名调查。
尽管克罗地亚有关于临床试验透明度的法律规定，但在公开领域它们的可见度仍然不够。在中欧和东欧国家中，克罗地亚在欧盟临床试验注册机构中注册的试验数量最少。调查中66%的患者知晓临床试验的存在，但只有15%的患者了解参与试验的可能性。尽管58%的受访者愿意尝试新疗法，但实际只有6%参与了临床试验。只有2%的受访者知晓公开可用的试验注册机构。
我们的研究表明，克罗地亚临床试验的透明度较低，克罗地亚患者并未充分了解临床试验及其参与可能性，尽管有报告称有互联网资源且与医生沟通良好。需要采取积极政策措施，提高克罗地亚患者对临床试验的认识并增加其获取途径，特别是以他们自己的语言。
