Clinical evaluation of new medicines began at the Pirogov Clinic of High Medical Technologies at St Petersburg University in 2019. Today, the largest Russian and international pharmaceutical companies trust the Clinic to evaluate the therapeutic efficacy and safety of the medicines they develop.
Dr Ivan Karnaukhov is oncologist and Head of the Department for Coordination of Experimental and Clinical Research at the St Petersburg University Clinic. He told us about how long a novel drug is to be investigated before appearing on the market, and what applications for a clinical trial at the University Clinic will be considered.
Dr Karnaukhov, could you tell us how and when clinical trials at the St Petersburg University Clinic started?
In February 2019, I was appointed Head of a newly formed unit – the Department for Coordination of Experimental and Clinical Research. From an organisational viewpoint, it was a start-up in its purest form with all the ensuing consequences and challenges. Nonetheless, my years of hands-on experience in clinical research and the comprehensive support of the Clinic’s administration enabled the successful and expeditious implementation of this very interesting and relevant, even if complex, project. It has been equally beneficial for both the Clinic and the University.
Did you understand at that time what goals and objectives you and your team are to achieve?
Yes, I did have a comprehensive plan with a clear set of goals and objectives for the new department, worked out in my head and laid out on paper. The first and foremost task was to build a team of professional and competent clinical research staff. The second important step was to create a research base for the Clinical Research Department – the Innovative Medical Therapy Unit. The next fundamental step, without which the first two would have been pointless, was to initiate clinical trials and successfully implement the clinical trials protocols.
Could you please tell us who contacts the University Clinic with clinical trial applications?
Currently, the overwhelming majority of clinical trial applications come from the largest and well-known international pharmaceutical manufacturers. They are very, very demanding with regard to the institution and specific units where the trial is carried out. We have a capacity to conduct trial on applications of almost any level of complexity and scale.
Would you please explain the steps for the assessment of a new medicinal product? Let’s say, a customer contacts the Clinic, and the application is approved. What happens next?
Clinical trials are time-consuming, multilateral and multi-stage medical research studies. In this type of clinical activity, all actions are strictly regulated by the approved protocol and by the norms of local and international law. It is also important to realise that clinical trials are preceded by lengthy preliminary studies at the preclinical stage. Preclinical studies are performed in laboratory: in vitro, on cell cultures or animal models (in vivo) for preliminary assessment of an experimental drug’s safety. Only if the outcomes of the preclinical studies are satisfactory, the clinical trial involving patients or healthy volunteers can be allowed.
After all legal and organisational issues have been settled, the clinical study approval by the Local Ethics Committee and the permission from the Ministry of Health have been obtained, the initiator of the study supplies the clinic with everything necessary to start the trial. This may include: additional equipment; documents; investigational medicinal products; and comparators to name just a few. Every clinical trial is designed to answer specific research questions. It has its own set of procedures, tests, examinations and other organisational nuances. Each research team member is therefore required to complete training for each and every trial protocol. Then the first stage of research involving people begins. It includes: obtaining written consent to participate in the trial; conducting medical examination of participants; and determining the participants’ eligibility.
All further treatment, examination and monitoring of the patients’ condition are carried out strictly in compliance with the protocol schedule. Moreover, the clinical study work must not interfere with the routine work in the hospital units, so that the quality of treatment and care would not decrease. In fact, our unit is unusual, because we treat patients only within the framework of clinical trial protocols; thus, maximising the quality of clinical research and medical treatment. Consequently, we can offer to our patients innovative therapies with unique mechanism of action.
How do patients react when they learn that they have the opportunity to participate in a clinical trial?
All participants in clinical trials – healthy volunteers or people with the disease / condition – are required to give voluntary informed consent and sign the informed consent document. Clinical researchers provide the participants with information about the goals, objectives, methods, procedures, expected results, risks and benefits of the research in an accessible form. I want to stress that participation in the clinical trial is voluntary, so participants can withdraw from the study at any time without giving a reason. Patients are closely monitored during all phases of the trial and are offered an optimal health care.
Indeed, at the very first meeting, there is some wariness on the part of the patients and their relatives. However, thoughtfulness and consideration, clear explanations about clinical trials in general and a specific protocol can inspire confidence and change attitudes. This is a necessary and essential part of the clinical research team’s work.
At times, there are conscious volunteers and patients, who request to participate in a clinical trial. This is especially true for diseases and conditions with extremely limited effective therapeutic possibilities. For this category of patients, participation in a clinical trial may be a chance not otherwise obtainable. Each patient’s case is individual, and we try to find an individual approach to each and every patient.
How many clinical trials have been conducted at the University Clinic so far?
Most often the clinical trial process takes from two up to five years, sometimes even longer. We got involved in clinical research studies only a few years ago. Therefore, I can tell you how many clinical studies the team of the Department for Coordination of Experimental and Clinical Research is currently conducting. These clinical studies are at different stages of the clinical trial life cycle. Since the opening of the Department, the Ministry of Health has approved 30 clinical studies in our clinic. Is it a big or a small number compared to other institutions? I’d say it’s insufficient in comparison with most of the major medical institutions in St Petersburg. On the other hand, considering that they have been doing clinical research studies for many years, whereas the Pirogov Clinic ventured into clinical studies only two years ago starting from zero, we are doing quite well. We are clearly on a progressive growth path with an annual increase in the number of studies.
What are the criteria for evaluating novel medicines?
Any clinical trial protocol has its own unique design and so-called milestones. In statistical analysis of research data, achieving or failing to achieve study-specific milestones gives the researchers information about the efficacy and safety of a novel medicine in therapy of a particular disease. Substantiation of the research hypotheses becomes the basis for the novel medicine approval and authorisation by the national regulatory authorities. After that the novel drug is approved for use outside of clinical trials, and, possibly, becomes a new standard therapy.
Why is it so important that medicines should be evaluated at leading research centres?
In clinical research, very high demands are placed on the qualifications of the research team, equipment, facilities and the research centre’s standards of work. At the moment, not all medical research institutions in our country can fully meet these requirements. Obviously, the initiators of clinical trials prefer to conduct research in the institutions that meet all the requirements. We can confidently say that our clinic meets all international quality requirements for the conduct of clinical studies in the fields of: oncology; nephrology; endocrinology; general internal medicine; gastroenterology and hepatology; anaesthesiology and resuscitation; rheumatology; and surgery to name just a few.
What, in your opinion, is the advantage of the St Petersburg University Clinic with regard to clinical trials over other organisations involved in clinical studies?
We have surpassed the majority of state medical institutions engaged in clinical trials in Russia. We established a specialised Innovative Medical Therapy Unit, where we do a full-cycle clinical research work. The global vision for our department is to create a safe and high-quality health care environment with the newest therapies implemented. We have highly qualified and experienced clinical research professionals and fully equipped facilities. I am confident that the prospects for the further development of the clinical research studies at the St Petersburg University Clinic are bright.