19 December, 2022
On 31 January 2022, European Commission Regulation No 536/2014 on the clinical evaluation of medicinal products for human use entered into force. On the same day, the European portal for clinical trials, the Clinical Trials Information System – CTIS, was launched.
Each institution involved in the conduct of a clinical trial must be registered with the Organisation Management Service (OMS) of the European Medicines Agency (EMA) and, on the basis of this registration, is assigned a unique ID under which it appears in the CTIS. It must also have an approved administrator for the CTIS portal, called Sponsors admin, who is empowered to approve/reject requests for CTIS user access within that organisation. For Masaryk University, this authorization was received on Friday 2 December 2022 by Assoc. MUDr. Regina Demlová, Ph.D. and Masaryk University has thus fulfilled all the necessary requirements and can now apply for clinical trial authorization via the CTIS portal. The processing will take place through the CZECRIN infrastructure, which operates under the MU Faculty of Medicine.
The SEOTP study was the first study to be submitted to the CTIS portal on behalf of Masaryk University on 6 December 2022. The aim of this study is to improve existing treatment approaches for psychosis and to innovate them based on genotype and endophenotype, including pharmacokinetic analysis, in order to minimise the adverse effects of olanzapine treatment and to obtain further information on the efficacy of this treatment.