CZECRIN – website
Hosting institution: Masaryk University
Partner institution: St. Anne´s University Hospital in Brno
Research infrastructure CZECRIN is a national infrastructure focused on the support of clinically oriented research in biomedicine through the support of investigator-initiated clinical trials (IITs). CZECRIN provides research, knowledge, methodological and service support for IITs and under organizational leadership of Masaryk University in the cooperation with St. Anne’s University Hospital in Brno creates an interoperable collaborative network of academic clinical research institutes in the Czech Republic. CZECRIN represents the Czech national node of the pan-European research infrastructure ECRIN (European Clinical Research Infrastructures Network), which is aimed at promoting the IITs at the EU level. The key areas addressed by CZECRIN are: regulatory and knowledge support, including quality assurance within the accreditation procedures and the preparation of complete study documentation for IITs; clinical application support ensuring biometry, monitoring, pharmacovigilance and systematic educational programme comprehensively covering the IITs; and research and development activities, including manufacturing of new advanced therapy medicinal products (ATMPs). Clinically oriented research initiated by the investigators is very specific for its characteristics and direct association with the patients, which may benefit from its results. Since there is a direct connection with the patients, whose safety is a priority, a high extent of regulation and exacting requirements both on national, and European level are applied concerning ethics, data security, qualification of the personnel, and organisational assurance. The critical point for future development of IITs is also the new Clinical Trials Directive issued by European Commission, which substantially changes the system of clinical trials in the EU and thus also in the Czech Republic. Without functional infrastructure that is able to assure research, knowledge, methodological, and service support, IITs cannot be performed. The results of independent academic clinical trials lead to the individualization, increase in efficiency and personalization of expensive treatment modalities.
CZECRIN will develop its activities in order to further expand the research support for the implementation of applied biomedical research through IITs conducted in the key areas of origin and development of diseases, new diagnostic and therapeutic methods, epidemiology, and prevention of the most serious diseases. CZECRIN will help to maximize the utilization of the research potential in the application environment, therefore with the direct impact on the patient health. Development of CZECRIN as the Czech national node within the ECRIN will allow better linking of Czech clinically oriented research organisations with application sphere at the EU level. Research and development activities of the infrastructure CZECRIN are focused on and will expand particularly in the priority areas of biomedical research, such as advanced therapy medicinal products (ATMP), orphan diseases, paediatric population, and personalized medicine.
The fundamental aim and vision of the research infrastructure CZECRIN lies in the support of independent academic clinical research and thus in the increase of expert level and international prestige of Czech scientific community oriented at clinical research. This vision appears urgent mainly in the context of recent significant investments in the research infrastructures in the Czech Republic, which are producing large quantity of basic and preclinical research results. Translation of these results into real clinical settings is not possible without the subsequent step, which is a proof of their clinical relevance in clinical trials phase I-IV. Strategic development of the biomedical research infrastructure aimed at clinical research and clinical trials is essential to utilize resources invested into scientific excellence and for maximization of scientific potential in the application sphere. All of these aspects are important both for the future users of the scientific results, i.e., patients, and for the prestige of Czech science in the European context of clinical research. CZECRIN, by focusing on the key elements of support for IITs through research, educational, methodological and regulatory support across the various disciplines of medicine, has major social implications in the translation of biomedical research results into clinically applicable outputs, such as new drugs, medical procedures, and practice guidelines. This potential can be exploited by business sphere and cooperation with business partners is promoted even on the basis of a collaborative contract research in accordance with the policy of the ECRIN-ERIC. An important part and one of the priorities is the area of ATMPs with the production of unique, individual, cell- and gene-based therapeutics focused on cancer and regenerative medicine.