Key features of the regulatory framework for clinical trials
The main purpose behind clinical trials of Medical devices (“Clinical Trials”) is to confirm that under normal conditions of use the Medical device (“the MD”) performs one or more of its functions determined by the manufacturer and to identify adverse side effects under normal conditions of use of the MD at issue. Clinical Trials are also designed to assess the extent to which any adverse side effects identified are within the acceptable risk, which is assessed in comparison with the benefit of the intended purpose of use of the MD.
First and foremost, Clinical Trials cannot be conducted without prior authorisation from the respective authority (e.g. the Executive Drug Agency – in Bulgaria; the State Institute for Drug Control – in the Czech Republic; the Health Board – in Estonia; the National Institute of Pharmacy and Nutrition – in Hungary; the Bioethics Committee – in Lithuania, the State Institute for Drug Control – in Slovakia). In Belarus, on the other hand, Clinical Trials can be performed only in investigation centres which are established in state health care organizations.
Secondly, a favourable opinion from specially designated ethics committees is an important prerequisite for performing Clinical Trials. Ethics committees are independent bodies whose main function is to supervise and review the scientific, medical and ethical aspects of Clinical Trials.
The authorisation procedure can be triggered by the manufacturer of the particular MD subject to clinical trials or their authorised representative. The manufacturer or authorised representative has two options: to obtain a preliminary opinion from the ethics committee and then proceed to apply for a permit (as is the case in Belarus, Bulgaria, the Czech Republic, Estonia Hungary, Latvia, Lithuania, Slovakia, and Poland) or file an application for authorisation directly with the respective body (applicable for Hungary).
Upon completion of Clinical Trials, the manufacturer or authorised representative has to present to the respective authority a final report containing a description of methodology and organization, critical assessment and statistical analysis of data received. In most CEE countries (e.g. Belarus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Slovakia, and Poland), the possibility of referring to Clinical Trials with similar but other MDs exists, provided that the equivalence of the MDs can be duly proved.
As outlined above, the regulatory framework in each country has its own specifics which have to be observed when performing Clinical Trials of MDs.