Title (croatian) Važnost provođenja randomiziranih kliničkih istraživanja Title (english) Importance of conducting randomised clinical trials Author Davor Štimac Author Alojzije Lacković Author Goran Poropat Author's institution University of Rijeka Scientific / art field, BIOMEDICINE AND HEALTHCARE Abstract (croatian) Kliničko ispitivanje (pokus ili studija) smatra se jedinim znanstvenim dokazom djelotvornosti nekog lijeka, terapijskog ili kirurškog zahvata. U posljednjih 50 godina, dominantan oblik istraživanja u medicinskoj znanosti postala su randomizirana klinička istraživanja (eng. Randomised clinical trials; RCT) te danas predstavljaju kamen temeljac medicine temeljene na dokazima (engl. Evidence based medicine; EBM) Riječ je o kvantitativno komparativnom obliku istraživanja pomoću kojeg se uspoređuje učinak dvaju ili više postupaka na ispitanike, koji su nasumično podijeljeni u više istraživačkih skupina. Stupanj dokaza, dobivenih pomoću randomiziranih kliničkih istraživanja, predstavlja najviši stupanj dokaza u medicinskoj znanosti, a smjernice koje predstavljaju sistematizirane principe liječenja uglavnom se temelje na najboljim dostupnim podacima iz kliničkih istraživanja. Smjernice omogućuju liječnicima da uz pomoć svog iskustva i znanja, vodeći pritom računa o osobitostima i stavovima bolesnika, najbolje liječe bolesnika. Pouzdanost i kvaliteta rezultata RCT-a, ovise o određenim karakteristikama samog istraživanja poput adekvatno provedenog postupka randomizacije, „zaslijepljenosti“ istraživača i ispitanika, te pravilno oblikovanom protokolu istraživanja. Usprkos velikom broju prednosti, postoje i određene negativne karakteristike randomiziranih kliničkih istraživanja, poput etičkih pitanja opravdanosti istraživanja, cijene, nemogućnoti provedbe samog istraživanja te nedovoljno dobre informiranosti pacijenata o važnosti njihova provođenja,kako za medicinsku znanost tako i za njih same.
Abstract (english) Clinical trial (experiment or study) is considered to be the only scientific evidence of the efficiency of a drug, therapeutic or surgical procedure. In the last 50 years, randomized clinical trials (RCTs) have become the dominant form of research in medical science and today they represent the base of Evidence Based Medicine (EBM). RCTs are quantitative comparative controlled experiments in which the effect of two or more clinical procedures is compared on subjects randomly divided into several research groups. The level of evidence, obtained through randomized clinical trials, represents the highest level of evidence in medical science, and the guidelines that represent systematized principles of medical treatment are mainly based on the best available clinical data. Guidelines allow physicians, in combination with their own experience and knowledge, while simultaneously taking care of personality and charateristics of patients, providing patients the best available treatment. Quality of RCT results depends on certain characteristics of the research itself, such as the adequately conducted randomization procedure, the "blindness" of researchers and subjects and properly designed research protocol. Despite the great number of advantages, there are certain negative characteristics of randomized clinical trials, such as ethical questions of justification of the research, price of the research, impossibility to carry out the research itself, and inadequate knowledge of patients about the importance of their implementation, both for medical science and them.
Keywords (croatian)
medicina temeljena na dokazima
randomizacija
zaslijepljenost
Keywords (english)
blinding
evidence-based medicine
randomisation
Language croatian Publication type Scientific paper - review paper Publication status Published Peer review Peer review Publication version Published version Journal title Medicina Fluminensis : Medicina Fluminensis Numbering vol. 53, no. 4, pp. 448-453 p-ISSN 1847-6864 e-ISSN 1848-1868 DOI https://doi.org/10.21860/medflum2017_187364 URN:NBN urn:nbn:hr:184:176315 Publication 2017-12-01 Document URL http://hrcak.srce.hr/187364 Type of resource Text Access conditions Open access Terms of use Created on 2017-12-27 08:36:43
