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

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.

Reporting violations of European Charter of Patients’ Rights: analysis of patient complaints in Croatia

“…Many questions about the healthcare system, as well as infringements of the Right to Information, which was the second most common patient complaint to the CAPR, could point out low health literacy in Croatia. Health literacy is a broad concept—a set of skills needed to function and understand the healthcare environment [ 59 ], ranging from understanding health information to health numeracy [ 60 ]. Low health literacy seems to be associated with poorer health outcomes [ 61 ], and different information about health or the healthcare system should be easily accessible to low-level health literacy patients [ 62 ].…”

Reporting Violations of European Charter of Patients’ Rights: Analysis of Patient Complaints in Croatia

“…Many questions about the healthcare system as well as infringement of the Right to Information, which was the second most common patient complaint to the CAPR, could point out to low health literacy in Croatia. Health literacy is a broad concept -a set of skills needed to function and understand the healthcare environment (45), ranging from understanding health information to health numeracy (46). Low health literacy seems to be associated with poorer health outcomes (47), and different information about health or healthcare system should be easily accessible to low-level health literacy patients (48).…”

Uloga medicinske sestre u procesu provođenja kliničkih ispitivanja

“…Jedan od razloga za ovakve predrasude nedovoljna je educiranost javnosti o kliničkim ispitivanjima. Postoji vrlo malo informacija u lite-raturi o tome koliko su ljudi u Hrvatskoj informirani o kliničkim ispitivanjima [5]. Između ostaloga, razlog tomu je i činjenica da većina informacija o kliničkim ispitivanjima nije dostupna na hrvatskom, nego na engleskom jeziku.…”

“…Iako je 66 % ispitanika bilo upoznato s kliničkim ispitivanjima, samo njih 15 % znalo je za mogućnost sudjelovanja u kliničkom ispitivanju. Također, 58 % ispitanika bilo je voljno isprobati nove oblike liječenja, ali samo njih 6 % zaista je sudjelovalo u kliničkom ispitivanju [5].…”