
Сlinical trials with human subject for MD
When is it impossible to avoid conducting clinical trials with human subject on the territory of the Russian Federation? The cases in which it is necessary to conduct clinical trials with human subject are given in the Order of the Ministry of Health of the Russian Federation dated 30 August 2021 N 885n. In simple words, they can be formulated as the absence of the possibility of proving clinical effectiveness and safety of use by analyzing interchangeability (namely, the absence of an interchangeable device). One of the characteristics of these trials, in comparison with clinical trials in the form of clinical evaluation and in vitro diagnostic trials, is the need to obtain a permission to conduct clinical trials from Roszdravnadzor. This permission is issued after biocompatibility and technical trials, submission of a complete dossier and expert examination by Roszdravnadzor. Clinical trials with human subject are conducted in accordance with GOST R ISO 14155-2022 ("Clinical trials of medical devices with human subjects. Good Clinical Practice"). The most important and difficult part of the process is developing the trial design and calculating a sample of patient data sufficient to prove the clinical effectiveness and safety of the device being registered, taking into account all the stated indications for use. Positive experience with the medical device circulation abroad, clinical data in accordance with IMDRF obtained abroad can help as evidence of the adequacy of the sample size. Before conducting clinical trials with human subject, it is necessary to obtain the opinion of the Ethics Council for the Circulation of Medical Devices of the Ministry of Health of the Russian Federation, having previously prepared a trial programme, a study brochure, documents on the qualification of researchers, documents on insurance of trial subjects, informed consent, containing sufficient information for the patient about the forthcoming intervention and possible risks. As a rule, clinical trials with human subject are time consuming and require substantial preliminary preparation.