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Coronavirus and clinical trials – what slowed down and what accelerated

An interview with Maciej Jurkun, Director of Operations and Vice President of Pratia S.A. [joint-stock company] – the largest network of Clinical Research Centers in Poland, by Kamila Śnieżek.

At what point did you understand that coronavirus from distant China suddenly became a real threat to your work, to the health of patients and employees of Pratia centers, and may prevent you from continuing your clinical research?

The first alarming signal was information about the cancellation of the European Congress of the Society for Clinical Research Sites, at which we were to appear as panelists and candidates for the Site Patient Recruitment Innovation Award. This information reached us on March 6. Before, of course, we had heard about coronavirus, but the threat seemed very distant. However, when companies operating in our industry began to introduce restrictions on travel, for instance, and in Poland, a key decision was taken to close schools, the problem became quite real and began to affect us as well. And indeed – already in mid-March, patients began to cancel visits to our centers, and we felt from our partners a slowdown in business decisions. There was also information about the disruption in the operation of the Office for Registration of Medicinal Products – i.e. registration of new clinical trials.

Have you ever had to go into „safe mode” before, or is the current situation completely unprecedented?

This has never been the case before. Yes, the global financial crisis in 2008 had a significant impact on our work, but it was a strictly economic situation. For about two years, up to 70 percent, clinical trials in the US did not come out of the startup phase. It strongly affected our work, because the contracts we had signed with American partners simply did not come to fruition. It delayed us and prolonged the process of introducing new drugs and therapies, but in no way did it threaten, for example, the health of our team, as it is currently taking place.

 

What were the first steps taken by the management of Pratia after the epidemic threat was announced in Poland?

Our first move was the establishment of the central Pratia crisis team, which included the company’s management, medical experts and managers of individual centers. The team and local Pratia centers, which work closely together, monitored the changing situation in Poland every day from the beginning and worked out new solutions and procedures on an ongoing basis. Our industry is a heavily regulated environment, so initially, we had a flood of recommendations from the Office for Registration of Medicinal Products, Food and Drug Administration (FDA), European Medicines Agency (EMA), Association for Good Clinical Practice in Poland (GCPpl), as well as national consultants in many fields of medicine. Every day, we reviewed all the information that came to us and tried to implement all the recommendations. We undertook safety measures very early in order to reduce the risk of virus transmission: we introduced a telephone epidemiological interview with patients, we reduced the number of patient visits to the centers, reorganized the waiting rooms, provided the centers with additional disinfection liquids and all personal protective equipment, in accordance with WHO guidelines we also began to regularly ventilate and disinfect the rooms. In our centers in Poznań and Krakow, we quickly set up airlocks, that are separate areas at the entrance, where patients, as well as employees coming to work, are subjected to health assessment, i.e. temperature measurement, respiratory examination, and medical interview. Of course, we also introduced a rotational and partly remote work for some staff, we also have detailed procedures for screening the patient and employees suspected of coronavirus infection.

Have you developed new procedures for all your centers, or did each of them require different solutions?

There are currently eight Pratia centers operating in Poland, but these facilities are highly diversified because some of them are integrated with primary care, others are independent outpatient facilities, we also have a hospital center. We had to cover all areas with general procedures and refine them with separate instructions for individual centers. We introduced changes live, we discussed reorganization plans with our experts every day and tried to deal with new problems on an ongoing basis. We did not introduce a state of crisis that would prevent any of our centers from working, fortunately, there has been no situation so far where we would have to consider such an option. The effect of daily meetings and discussions of the crisis team was the creation of SOPs, i.e. standard operating procedures describing the implementation of additional safety measures for patients and employees during the SARS-CoV-2 epidemic. We have developed, for example, a procedure for remote delivery of the test medicine to patients who, for safety reasons, cannot come to the center for a visit – it is very important because otherwise, they would have to stop the therapy. Other new procedures include temporary suspension of on-site monitoring visits to centers and the introduction of remote visits and new guidelines for couriers delivering medicines to centers.

Have commercial Pratia centers been affected in a similar way as public facilities, i.e. staff and personal protective equipment shortages, as well?

Pratia is part of the Neuca Capital Group and from the very beginning, we are getting huge support from the parent company, including equipment. We are regularly supplied with disinfectants and personal protection products, so we keep an adequate amount of disinfectant fluids, masks, gloves, aprons, helmets, and other equipment necessary to work in current conditions. We do not have to be afraid that this protection will suddenly run out, we have guaranteed continuity of supply. Luckily, our full-time staff, who are working persistently in these new, harsh conditions, are taking care of our patients and fighting for the successful continuation of research. Of course, however, we are affected by external restrictions regarding the order for doctors to work only in one basic medical facility – reducing the availability of our researchers. Fortunately, since we converted some of our patients’ personal visits to remote ones, we have also managed to maintain their work continuity.

Have there been any solutions implemented that you are particularly proud of?

The pandemic situation has become a driving force for the digitization of clinical trials. We immediately provided sponsors with the option of so-called remote monitoring, i.e. remote monitoring visits at https://sites.google.com/pratia.com/rmq/. This is done using the Hyggio platform allowing remote access to blind copies of the source documentation and a copy of the study documentation in compliance with the GDPR and FDA 21 CFR Part 11 safety standards, based on procedures in accordance with the principles of good clinical practice. We are currently convincing other sponsors and CRO companies (organizations conducting clinical trials on behalf of pharmaceutical companies) to do so, and our proposal is becoming more and more popular. Remote monitoring was made available instantly, it was a pandemic need of the moment, but we are looking even beyond that – the Hyggio platform is a huge project, electronic documentation of clinical trials and a program for managing the center in one place, as well as a proposal for the center, CRO and sponsor. To this end, Pratia has co-financed Clinscience Technologies and intends to consistently support and promote the digitization of clinical trials.

 

How do Pratia centers operate today? Can the patients feel the changes?

Pratia currently employs over 100 people, from central structures to central staff, doctors, nurses, and clinical trial coordinators, all focused on patient safety in a clinical trial. First of all, all our centers work and try to keep patients in ongoing research – this is currently paramount in our activity, because for obvious reasons, active recruitment for most studies is suspended. We strive to make patients feel good and safe with us. Patients are always the most important in every Pratia center. We have introduced cassette tests in several centers, i.e. screening patient tests for the presence of anti-coronavirus antibodies. Every person entering the center can have such a test, and in the case of a positive result is subjected to further diagnostic tests. To strengthen the sense of security for particularly vulnerable people, we have created separate zones for immunocompromised patients, e.g. in hematology and oncology tests, and separate nursing and treatment rooms as well as consultation rooms for them. Our staff works on a rotational basis, we also introduced days without a patient when we accept monitors, i.e. representatives of sponsors and the CRO companies. We are considering starting to ozonate our centers. It must be made clear that almost everything related to our work has changed due to the pandemic, and we are trying to maintain business continuity, but focusing on the safety of all those involved in this process.

Are there any plans for further clinical research in Pratia?

Recruitment for new research has been suspended by sponsors, so the decision to resume it is not only up to us. The situation is difficult because some studies on biological drugs by definition reduce the patient’s immunity, which in the current situation is puzzling. On the other hand, as a biotechnologist and scientist, I want to look more broadly and think that SARS-CoV-2 pneumonia is not the only disease patients will be suffering from and dying in the following months and years. It is very important that we resume care and treatments in other areas of medicine as soon as possible. Cancer patients, cardiologist patients or diabetics also need treatment, and our work is to introduce new, effective therapies to the market. We are waiting with hope that bioethics committees will make the right decisions, sponsors will start releasing further research, URPL [Office for Registration of Medicinal Products] will start working in the normal mode, and we will get the green light from all of them. We are preparing for a post-pandemic reality, and I think that when our time comes, we will be ready.

What does your work look like now?

Everything has changed. There is a lot of work, there are also emotions – above all, huge stress and anxiety about the health and life of our patients, about the safety of staff, maintaining research continuity, or the financial situation of the company. These aspects have now become key, while business goals have faded into the background. There is no doubt that we conduct commercial activities – although our priority is to contribute to the development of medicine, we have never lost a business perspective and have always tried to keep our business profitable. Today’s current budget goals remain in the shadows, and what counts is the safe conduct of all of us, patients and staff, throughout the pandemic. However, we focus very much on preparations for increased work after lifting the lockdown – we are getting a lot of contracts, we focus on readiness to work in a new reality – I mean the digitization of clinical trials, but we are also establishing a new hospital clinical research center that will expand and strengthen our offer for sponsors.

What are your biggest fears and hopes now?

From the accounts of doctors who work with patients affected by coronavirus-induced pneumonia, I know that this is a serious, dangerous, and very rapid form of the disease. Because of fear of infection, public confidence in clinical trials, which are a kind of experiment, may not be as strong at present. However, I hope that our efforts to make patients not only feel safe but actually be safe during a visit to Pratia centers will help us to survive this difficult time. I am also sure that the huge contribution of science and medicine in the fight against coronavirus will soon bring the expected result – any project that can contribute to the development of a rapid diagnostic test, vaccine or effective therapy methods gives us all faith and allows us to look into the future with optimism.

* Pratia is the largest network of clinical research centers in Poland. It consists of eight professional medical facilities located in the largest cities in Poland and four Partner Centers. Pratia Clinical Research Center is characterized by experience, quality, and, above all, patient care.

Pictured: Maciej Jurkun, Director of Operations and Vice President of Pratia S.A., photo: Pratia press materials

Author: Kamila Śnieżek

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