Clinical trials (research) of medical devices at Saint Petersburg State University Hospital
An interview on the clinical trials (research) of medical devices with Dr Ivan Karnaukhov, researcher, oncologist and Head of the Department for Coordination of Experimental and Clinical Research at the Saint Petersburg State University Hospital/
In November 2018, the first agreement to hold clinical trials of medical devices was concluded at St Petersburg University’s Pirogov Clinic of High Medical Technologies. It was an entirely new direction of research at the St Petersburg University Clinic. The first steps were performed on a volunteer basis by a small group of clinical research scientists from several departments of the Clinic. In February 2019, the administration of the Clinic decided to establish a specialised department titled the Department for Coordination of Experimental and Clinical Research. The main directions of the Department activity include holding clinical research of medical drugs and trails (research) of medical devices with the goal of their further state registration. The right to conduct clinical trials (research) of medical devices was granted to the Clinic in July 2018 following its inclusion into the List of Medical Organisations created by the Federal Service for Supervision in Healthcare.
The tasks of the Department for Coordination of Experimental and Clinical Research include organising and coordinating the work at all levels and stages of every clinical trial (research) starting with negotiating the agreement with the customer to providing the results of the conducted research in accordance with the regulatory requirements.
Clinical trials (research) are conducted by research groups formed separately for every specific research activity. The group includes: an employee from the Department for Coordination of Experimental and Clinical Research, who coordinates the activity; and specialists in various fields depending on the profile of the medical device under study. Currently, the majority of clinical trials is being conducted following national requirements in the form of analysis and assessment of the clinical data without human participation. On average, it takes 30 calendar days to conduct one trial.
The main goal of holding clinical research of medical devices is to prove their safety and effectiveness, so that they can be further used in real clinical work in the Russian Federation (or in the Eurasian Economic Union if the trial (research) was held following the rules of the Eurasian Economic Union). Every research activity is unique, since the research group has to take into account a number of various factors on every device: the class of potential risk; the completeness of the provided documentation; the results of previous technical and toxicological trials; and the field of application to name just a few.
In the course of its activity, the Department has completed over 130 clinical and laboratory trials (research) of medical devices in the following fields:
- ophthalmology,
- urology,
- traumatic and orthopaedic surgery,
- paediatrics,
- otorhinolaryngology,
- gynaecology,
- surgery,
- anaesthesiology and intensive care medicine,
- laboratory equipment,
- surgical equipment,
- surgical tools,
- medical and laboratory expendables,
- medical software,
- dental care,
- neurology, etc.
Definitive advantages of holding clinical trials (research) of medical devices at the Saint Petersburg State University Hospital include the following:
- diversification that allows for almost any medical device to be tested;
- the Department for Coordination of Experimental and Clinical Research – a specialised subdivision with a testing laboratory for medical devices;
- specialists in the field of clinical trials (research);
- required infrastructure and equipment;
- wide range of option to hold clinical trials (research) in multiple locations of the Clinic.
Contact information
Contact the Hospital to consult about conducting clinical trials (research) of medical devices:
- +7 812 676 25 25 – call centre of the Hospital;
- info@medtrials.ru – email of the Department for Coordination of Experimental and Clinical Research
- i.karnaukhov@medtrials.ru – email of the Head of the Department for Coordination of Experimental and Clinical Research.