UPORABA STATISTIKE V KLINIČNIH RAZISKAVAH – ŠTUDIJA PRIMERA - Majster, Janez (2015)
Klinične raziskave so raziskave, s katerimi se preskuša učinkovitost in tudi varnost zdravila oziroma medicinskega izdelka ali postopka na bolnikih ter tudi zdravih prostovoljcih. Sodobne klinične raziskave so tesno povezane z uporabo statistike oziroma različnih statističnih metod. Kljub temu imajo mnogi raziskovalci v medicini zgolj osnovno znanje statistike in ne poznajo pravega načrtovanja raziskav, kar pogosto vodi do rezultatov, ki ne ustrezajo nivoju objave v strokovnih in znanstvenih publikacijah. Vzrok za omenjene težave se nahaja v napačnem pristopu do načrtovanja raziskav. Zato se dandanes mnogi raziskovalci za pomoč pri izvedbi načrtovanja raziskav obrnejo na strokovnjake iz statistike z drugih področij ali pa se sami temeljito poučijo o številnih možnostih uporabe statistike v kliničnih raziskavah. Pri izvajanju kliničnih raziskav je ključnega pomena načrtovanje, saj se v tej fazi predvidijo vsi pomembnejši elementi raziskave. S statističnega vidika je od faze načrtovanja odvisno tudi zbiranje statističnih podatkov ter analiza le-teh. V preteklosti so bile v mnogih kliničnih raziskavah večinoma izvedene le osnovne statistične analize, vprašalniki so bili enostavni ter prilagojeni načinu analize. Večina rezultatov je bila pridobljena le na podlagi preproste opisne statistike in zato ne ustreza standardom objav v strokovnih in znanstvenih publikacijah. Namen diplomskega dela je pregled uporabe statistike v kliničnih raziskavah skozi zgodovino ter praktičen prikaz statistične analize klinične raziskave faze IV, ki je bila narejena v farmacevtskem podjetju in pri kateri so preučevali učinkovitost in sprejemljivost določenega zdravila, registriranega na slovenskem trgu. Podatke smo analizirali s pomočjo računalniškega programa SPSS v20. V diplomskem delu želimo opozoriti na napake, ki se najpogosteje pojavljajo, ter nakazati, kako se jim raziskovalci lahko izognejo. Clinical research is a research that tests the effectiveness and safety of medicines and medical devices or procedures on the patients or healthy volunteers. Modern clinical researches are closely related to the use of statistics or different statistical methods. Experiences show that many researchers in clinical researches have only a basic knowledge of statistics and research planning. This often leads to results which are not appropriate to be published in professional publications. The reason for these problems is the wrong approach in research planning. Today many researchers in clinical researches are using help from statistics experts from other areas or they study on their own about different possibilities of statistic usage in clinical researches. Planning is crucial element in conducting of the clinical research, because at this stage all the essential elements are provided. The collection and analysis of statistical data also depends from this stage of the clinical research. In the past, in most of the clinical trials only basic analysis were carried out, questionnaires were simple and adapted to the method of analysis. Results of those analyses reflect the average and are suitable only for local presentations. The purpose of the thesis is a review of statistics usage in clinical trials through the history and review of the design and implementation of clinical trials. This thesis presents also a short statistical analysis of real data from clinical trial using a computer program SPSS. The thesis concludes that the use of statistics should be included from the beginning of the clinical trial. Statistics should be used also in the phase of conduction of clinical trials, where the cooperation between doctors or planners and statistics experts is crucial.