University of Zagreb. School of Medicine. Chair of Social Medicine and Health Care Organization.
Abstract
Klinička ispitivanja je nužno provoditi prije nego li se neki lijek počne primjenjivati u širokoj
populaciji. Svako kliničko ispitivanje je pomno isplanirano, kako bi dokazalo djelotvornost lijeka, ali i
ukazalo na štetne učinke.
Kako se klinička ispitivanja provode na ljudima moraju biti u skladu sa dobrom kliničkom praksom,
koja je definirana međunarodno priznatim i prihvaćenim etičkim i znanstvenim standardima za
planiranje, provođenje i praćenje kliničkih ispitivanja.
U kliničkim ispitivanjima primjenjuju se ista etička i pravna načela koja vrijede za medicinsku praksu,
ali su puno strože kontrolirana međunarodnim i nacionalnim zakonima i propisima, a sve u svrhu
najvišeg stupnja zaštite prava i sigurnosti ispitanika gdje se sigurnost ispitanika stavlja ispred
znanosti.
Svaki pojedinac koji sudjeluje u kliničkom ispitivanju mora biti osposobljen, educiran, uvježban i
iskusan za obavljanje zadataka koji mu je dodijeljen u ispitivanju.
Medicinska sestra je neizostavan član tima za provođenje kliničkih ispitivanja, ali do sada nedovoljno
priznat i sa malo dokaza koji to potvrđuju.
Stoga se ovim radom želi naglasiti njihova uloga, a sudjelovanjem u kliničkim ispitivanjima osigurati
područje sestrinske skrbi. Kompetentnost medicinskih sestara u kliničkim ispitivanjima je neupitna,
ali je potrebno više dokaza kroz objavljivanje radova koji će govoriti u prilog tome.Clinical studies should be performed before a drug is to be administered to a wider population. Each
clinical trial is a carefully planned, in order to prove the effectiveness of the drug, but also to point out
its harmful effects.
As the clinical trials is conducted on humans it must be in accordance with good clinical practice,
which is defined by internationally recognized and accepted ethical and scientific standards for the
planning, implementation and monitoring of clinical trials.
The same ethical and legal principles that apply to medical practice are also valid in clinical trials.
However, these principles are stringently controlled by international and national laws and
regulations, all aimed at the highest level of protection of the rights and safety of patients, where the
safety of patients is placed in front of science.
Each individual who participates in a clinical trial should be qualified, educated, trained and
experienced in performing the tasks assigned to him/her in the study.
The nurse is an indispensable member of the team which conducts clinical trials. However, their role
was not sufficiently recognized, and there is little evidence about it.
Thus, this paper aims to emphasize their role and participation in clinical trials in order to ensure this
role in this area of nursing care. The competence of nurses in clinical trials is unquestionable, but
needs more evidence through the publication of works that will speak in favour of it
