Ovrednotenje sistema kliničnih preskušanj zdravil za uporabo v humani medicini v Sloveniji

Voh, Žana (avtor), Kos, Mitja (mentor), Savinek, Vane (komentor)

Število vlog za klinična preskušanja se je v Sloveniji v zadnjih 10 letih gibalo med 18 in 38 na leto, kar je relativno malo v primerjavi z drugimi evropskimi državami. Namen magistrske naloge je bil ovrednotiti sistem kliničnih preskušanj v Sloveniji. Izvedli smo dve raziskavi. V raziskavi z vidika farmacevtskih podjetij smo s pomočjo vprašalnika ugotavljali, v kolikšni meri so dejavniki, ki smo jih povzeli iz literature, vplivali na odločitev podjetja, da se v Sloveniji klinična preskušanja v preteklih 5 letih niso izvajala v večjem obsegu oziroma se sploh niso izvajala. Vpliv dejavnikov smo vrednotili na 5-stopenjski Likertovi lestvici. Vprašalnik smo posredovali 43 inovativnim in generičnim farmacevtskim podjetjem, vrnilo pa nam ga je 20 podjetij. Za namen druge raziskave z vidika vseh ključnih deležnikov v sistemu kliničnih preskušanj smo izvedli fokusno skupino, v kateri je sodelovalo 10 predstavnikov vseh ključnih deležnikov – predstavniki izvajalcev kliničnih preskušanj, predstavniki regulatornih organov, predstavniki farmacevtskih podjetij in predstavniki pogodbenih raziskovalnih organizacij. Kvantitativne podatke iz vprašalnika smo obdelali s pomočjo programa MS Excel 2010, kvalitativne podatke iz obeh raziskav pa v programu NVivo Pro 9, pri čemer smo pri obdelavi podatkov fokusne skupine najprej naredili transkript, nato pa smo kodirane zapise iz vprašalnika in fokusne skupine uvrstili v posamezne teme. Rezultati vprašalnika so pokazali, da sta imela največji vpliv na odločitev podjetja o neizvajanju kliničnih preskušanj sistem urejanja pogodbenih odnosov v ustanovi, kjer se izvajajo klinična preskušanja in motiviranost glavnega raziskovalca, sledili pa so dejavniki, vezani na velikost trga, hitrost odobritve vlog etične komisije, število, usposobljenost, odzivnost in motiviranost študijskega osebja ter znanje, izkušenost, veščine in druge delovne obveznosti glavnega raziskovalca. V fokusni skupini pa so se kot pomembni dejavniki izpostavili predvsem hitrost odobritve vlog etične komisije, pomanjkanje kadrov in raziskovalnih oddelkov v ustanovah, urejanje pogodbenih odnosov v ustanovah in slabo poznavanje smernic dobre klinične prakse. Kot možno rešitev so izpostavili sodelovanje vseh ključnih deležnikov pri ustvarjanju bolj ugodnega okolja za izvajanje kliničnih preskušanj v Sloveniji.

• Jezik: Slovenski jezik
• Ključne besede: klinično preskušanje, sistem kliničnih preskušanj, izbor mesta kliničnega preskušanja, izbor države kliničnega preskušanja, Slovenija
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2019
• PID: 20.500.12556/RUL-106138
• Datum objave v RUL: 31.01.2019

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Evaluation of the clinical trials system for human medicinal products in Slovenia

Izvleček

In the last 10 years, the number of clinical trial applications in Slovenia ranged between 18 and 38 per year, which is relatively low compared to some European countries. The purpose of the master's thesis was to evaluate the system of clinical trials in Slovenia. We conducted two investigations. To investigate the aspect of the pharmaceutical companies we developed and used a questionnaire to determine what was the level of influence that a certain factor had on the decision of the company not to conduct clinical trials in Slovenia in greater extend or at all in the last 5 years. The influence of the factors that were identified from the literature was evaluated on 5-point Likert scale. The questionnaire was sent to 43 inovative and generic pharmaceutical companies of which 20 companies returned it. The purpose of the second investigation was to research the aspects of all key stakeholders of the system of clinical trials. For that we carried out a focus group where 10 participants represented key stakeholdes - representatives of clinical trial researchers, the regulatory bodies, the pharmaceutical companies and the contract research organizations. Quantitative data from the questionnaire was processed with MS Excel 2010 program while qualitative data from both investigations was processed with NVivo Pro 9. For the processing of the focus group data, we first created a transcript, followed by classification of the references from the questionnaire and the focus group into individual topics. The results of the questionnaire showed that the administrative requirements (forms, contracts, signatures) by the clinical trial site institution and the motivation of the principal investigator had the greatest influence on the decision of the company not to conduct clinical trials in Slovenia, followed by factors related to the size of market, speed of approval of the clinical trial application by the Ethics Committee, number, qualifications, responsiveness and motivation of the study staff, knowledge, experience, skills, and concurrent workload of the principal investigator. Speed of approval of the clinical trial application by the Ethics Committee, lack of staff and research departments in the institutions, institutional contracting system and the poor knowledge of the guidelines of good clinical practice were recognised as important factors in the focus group. The participation of all key stakeholders in creating a more favorable environment for conducting clinical trials in Slovenia was highlighted as a possible solution.

• Ključne besede: clinical trial, system of clinical trials, site selection, country selection, Slovenia