The conduct of clinical trials in Slovakia was the main theme of the two-day meeting on the occasion of the International Day of Clinical Trials organised on 15 and 16 May 2023 by the National Node for Academic Clinical Trials in Slovakia SLOVACRIN, covered by the Faculty of Medicine UPJŠ in Košice together with the Ministry of Health of the Slovak Republic, the State Institute for Drug Control and the Association of the Innovative Pharmaceutical Industry.
Participants of the conference discussed, among other things, the development of a number of clinical trials in Slovakia, or how to bring in innovative treatment options linked to ongoing research by Slovak patients. At the conference there were interesting contributions from both academic and commercial research. The main theme, which resonated in all departments, was the interest in bringing new, beneficial and safe procedures, medicines and materials for therapeutic practice and proactive efforts to find effective solutions. observed the medical director of infrastructure SLOVACRIN MUDr. Beata Čečeková, PhD.
Among the speakers were representatives of the Ministry of Health of the Slovak Republic, the State Institute for the Control of Medicinal Products, commercial and non-commercial sponsors, medical institutions, examiners, as well as patient organisations. The director of the partner CZECRIN doc also accepted the invitation to the meeting. Dr. Regina Demlová, PhD., who reported on the current clinical trial situation in the Czech Republic.
The lectures and discussions provided different insights into the conduct of clinical trials and gave participants a comprehensive description of the current issue. The topic of identifying problems and possible solutions for the future has been raised, which would improve the environment for conducting clinical trials and allow my country to be fully competitive in the European area. At the same time, an initiative was launched to create a working group of MZ SR, which will define the main but avoidable obstacles to increasing the number and benefit of clinical studies in Slovakia.

One of the objectives of SLOVAKIA's infrastructure is to support the training of staff of the Clinical Trials Departments and study teams to ensure the conduct of clinical trials in accordance with good clinical practice. Therefore part of the meeting was also certified Good clinical practice course for investigators and coordinators. It was a professional event with high participation of participants from health institutions in the scope of MZ SR, private hospitals, outpatient health care providers, representatives of scientific and research institutions, universities and the commercial sphere. The aim of this course was to promote systematic clinical trial learning, to direct initial clinical trial departments and coordinators, and to share knowledge and experience acquired; told the medical director of infrastructure SLOVACRIN MUDr. Beáta Čečeková, PhD.
SLOVAKIA (Slovak Clinical Research Infrastructure Network) was established in 2018 as a national node for academic clinical trials in Slovakia and its activities are coordinated by the Faculty of Medicine of the University of Pavol Jozef Šafárik in Košice. It is a national research infrastructure linking hospitals, universities and scientific institutions involved in academic clinical research, which is the national partner of the ECRIN International Research Infrastructure Network. ECRIN, based in Paris, is a non-profit intergovernmental organisation supporting the conduct of international non-commercial clinical trials in Europe, bringing together scientific partners and national networks.
The last year was a breakthrough for clinical trials not only in Slovakia but also throughout the European Union. states the director of the national infrastructure SLOVACRIN Prof. MUDr. Daniel Pella, PhD., cardiologist at the Faculty of Medicine UPJŠ in Košice and at the Východoslovenský Institute of Heart and Vascular Diseases.
Regulation for clinical trials is provided in Slovakia by the State Institute for Drug Control. 31.1. 2022 new legislation for clinical trials across the EU has entered into force. Together with the entry into force Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use (CTR) has also been launched in all EU countries by the Clinical Trials Information System (CTIS). The State Institute for the Control of Medicinal Products has been intensively prepared for the implementation of the new legislation and the result is that Slovakia has so far received 44 applications for clinical trials, where it acts as the Member State concerned.The SWD was also proposed twice as rapporteur Member State and we came forward as a country three times and we were subsequently appointed rapporteur Member State, added Luke Slovak, Head of the Clinical Trials Department. Currently, Member States are working to address any deficiencies that have occurred in the assessment of clinical trials since the entry into force of CTR and the launch of CTIS.
SLOVAKIA shall be part of ECRIN-ERIC for the fifth year and shall succeed in achieving the objectives set in the umbrella of academicly initiated clinical trials in Slovakia. It provides complete service for clinical trials organized by researchers, supports the preparation and implementation of academic clinical trials in Slovakia, including international ones, provides management of clinical trials and complete project management, regulatory activities, monitoring and pharmacovigilance for national and international academic clinical trials.
International day of clinical trials is mentioned annually in May with reference to the first controlled scientific study of 1747 when Scottish doctor James Lind compared different treatments for scurvy-scurvy seafarers after two months of sea voyage.A study published in the Treatise of the scurvy in 1753 compared the impact of different diets on health among six groups, while Lind found that sailors receiving lemons and oranges had a disease resolution (and partly helped to consume cider) - although he did not understand the real causes of vitamin C deficiency.James Lind thus laid the foundations for modern clinical research, which in the developed form of clinical trials of active substances is currently used to verify the efficacy, quality and safety of medicinal products.