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Clinical trials in the shadow of a pandemic

About changes in the functioning of the center triggered by the pandemic and difficult emotions – Kamila Śnieżek talks to Małgorzata Gerjatowicz-Osmańska, the Director of Pratia MCM Krakow Clinical Research Center.

What does Pratia MCM Krakow Clinical Research Center do?

Pratia MCM Krakow Clinical Research Center, operating as a part of Pratia network, is one of the largest clinical research centers in Poland. As one of the centers taking part in international multicentre studies, we have been collecting clinical data for over 25 years to determine the effectiveness and safety of new drugs.

Our facility consists of a specialized research center and a hematooncological research center, and currently, it conducts approximately 80 different clinical studies in the field of oncology and hematology, as well as research in chronic autoimmune diseases, e.g. rheumatoid or psoriatic arthritis, ankylosing spondylitis, psoriasis as well as osteoporosis, diabetes, osteoarthritis and neurological diseases such as Parkinson’s disease or Alzheimer’s disease. In addition, we provide specialized medical advice outside the NFZ [Polish National Health Fund] system.

Who are the employees of Pratia Krakow?

We employ a total of about 60 people. Our full-time team consists of doctors, nurses, pharmacists, and medical registration clerks. Additionally, several dozen specialist doctors in various fields of medicine cooperate with us, and at the same time, they provide medical advice or are principal investigators in our clinical trials. In addition to medical personnel, we also have clinical research coordinators, who are essential for the proper functioning of all clinical trials centers. It is a group of twenty people who bear the burden of organizing visits and coordinating the work of research teams, overseeing patient safety and ensuring that the clinical trials are conducted in compliance with the International Principles of Good Clinical Practice (GCP). We also employ an administration team dealing with servicing the clinical research office, preparing documents necessary to start new trials and accounting.

Let’s talk about patients now. How many of them are there?

Currently, under our constant care in clinical trials, we have about 1,000 patients, who are visiting our center at a frequency determined by the clinical trial protocol. For some of them, it means that a visit to our center is necessary even several times a week, others appear less frequently, e.g. once every few weeks or months.

We are an outpatient center and during a single visit, patients stay with us for several hours. Depending on the protocol of the clinical trial, such a visit consists of a medical examination, completing questionnaires regarding the patient’s well-being, collecting samples for laboratory tests, imaging tests, administration of the experimental drug, and observation following administration. We carry out nearly 700 visits per month, according to various research protocols. In addition, we provide specialist medical advice, and in our patient base currently, there are about 50,000 people.

 

The coronavirus pandemic shut down many companies and medical practices. Has it also threatened Pratia’s clinical trials?

The current situation is, of course, having a huge impact on our activities, but we absolutely cannot allow the interruption of ongoing research. We are responsible for our patients during their treatment and we must not leave them unattended and without further doses of the study drug. Given the epidemiological risks, we operate so that some patient visits can be carried out remotely, rather than personally, as it was before. These changes are determined individually for each patient and each drug program, always based on the analysis of the ratio of the risk when the patient leaves the house against the benefits of them arriving at the center.
Mostly, we have limited visits that are not related to medical examinations and drug administration. The ones that must take place are preceded by a phone interview, during which patients are given an epidemiological survey taking into account the risk factors of coronavirus infection for the patient and his relatives. Patients with suspected infection are not invited to the center, but we are trying to provide for them remotely, and in a similar way we treat patients for whom leaving home could pose too high a risk due to their medical problems. Other patients who come to us go through all our security procedures.

How do you protect your patients and employees?

Upon arrival at the center, not only each patient but also every employee goes to the special lock, where he is received by properly prepared staff, and under their watch, he or she washes and disinfects their hands and is also provided with a surgical mask. An epidemiological survey is conducted for the second time, as something may have changed since the phone call. The lock staff also measures the patient’s temperature, and if something is worrisome, the attending physician or doctor on duty is called. However, if the patient’s condition does not raise any objections, they go for their scheduled visit. It is worth adding that our patients receive reimbursement of travel costs to the center, so regardless of their financial situation, they do not have to choose solutions that are currently not secure, i.e. public transport, but they can safely reach us by car or taxi.

Before the pandemic, 40-60 patients came through the center each day. Thanks to remote visits today there are fewer of them, and we try to spread their visits as safely as possible throughout the day, using all floors of our center and reorganizing the waiting room system. In the waiting rooms and in the corridors and mezzanines, we have arranged seating in such a way that patients maintain safe distances among themselves. We also have dispensers with disinfectant fluid in all parts of the building and we encourage everyone to use them often. Our staff is trained and prepared to work in epidemic conditions. Double epidemiological screening before each patient’s visit is to protect us from contact with infected people, however, of course, it will not prevent contact with infected but asymptomatic patients. Doctors and nurses use personal protective equipment, i.e. face masks, gloves, visors, and scrubs/protective suits. We have also adopted the tactic of minimizing direct contact between medical and administrative staff. We all wear masks with which the company supplies us.

 

Has coronavirus changed the mode of operation of the site? Do you work remotely?

We try not to disappoint our patients and prevent the interruption of their therapies. In our case, it seemed to us that remote work would be difficult to carry out, but the situation forced us to seek different, sometimes very creative solutions. First of all, we work on a rotational basis (alternately in the office and remotely) to minimize the number of people staying simultaneously in the center. We’ve all gone through an accelerated course of work on shared documents on the web. Pratia has also launched the option of securely sharing the documents we need to work on in the innovative Hyggio system.

There is certainly no less work than before the epidemic and it is performed in much more difficult conditions and under high stress. We are all far more mentally burdened than before, in the days before the pandemic.

Are the patients in the center more concerned with their health and the success of the therapy?

It is known that patients with chronic diseases, e.g. oncological or autoimmune diseases, and thus with reduced immunity, are most at risk when it comes to complications with Covid-19. And these are definitely our patients! Especially since we treat many of them with the help of drugs that additionally modify their immunity.

In our center, the basic issue is now the safety of our patients and employees, hence the changes in the mode of operation of the facility, which are to reduce the risk. Strong emotions are on both sides, but patients are primarily concerned. Fortunately, we can see that they have confidence in their attending physicians, who carefully analyze each situation and advise on the best solutions.

Our patients follow the instructions. They come to the center and undergo security procedures, and if the doctor finds it too risky, they stay at their homes and use tele-visits, or take advantage of the home delivery of another dose of the test medicine. We all want to give them a sense of security and we strive to protect both ourselves and them at the same time.

And the emotions of your employees? Do you feel particularly vulnerable?

Our patients are at high risk, but this does not mean that they pose an extremely high threat to us, the Pratia staff. Paradoxically, the most vulnerable people protect themselves better and in a much wider way than the others – they do not leave the house, do not stay in public places, isolate themselves from people they do not need to contact and use the help of their families who are usually aware of the seriousness of the situation and also take all possible precautions.

In my opinion, incidental contact with E.R. patients, and even with grocery store customers, is much less secure. However, it is obvious that we are all accompanied by strong emotions, everyone is somewhat afraid for themselves and their family, to whom they return after work. I am full of admiration for the maturity and commitment of all our employees. Permanent staff are aware of the importance of patient safety and the success of their therapy, so although they probably would like to be locked up at home, they still come to work and follow all necessary safety procedures. Although we are a huge team of several dozen people and we work on a rotational basis, we try to maintain telephone contact or instant messaging with every employee so that nobody feels lonely. We also try to systematically send messages to our teams and cooperating doctors so that they know what precautions they can expect in order to increase their safety. Anyway, we receive signals from them that they feel much better protected in Pratia than in other medical units, where they also work. We are certainly not perfect, but we try our utmost.

 

Are you planning any clinical trials related to Covid-19 treatment or coronavirus vaccines?

We are not the kind of center that could conduct research on the treatment of patients with Covid-19, but we declare our full readiness for research on new vaccines. Our partners know this and are taking our facility into account. If and when Poland will be able to conduct such research, Pratia, as a large and important network of centers, will probably be involved in it.

The current situation has another important aspect for the success of all other ongoing clinical trials. It is about the integrity of data obtained in the context of an epidemic. Although we have clear rules on how to deal with patients, there were no recommendations on what to do with the data obtained in these difficult conditions. It would have to be obtained in such a fashion so it would not be disturbed in any way, that would prevent a reliable analysis of the effectiveness and safety of the tested drugs and then, consequently lead to their registration and subsequent patient treatment. As managers of Pratia centers, we are active within the working groups of the Association for Good Clinical Practice in Poland (GCPpl) developing guidelines for how to deal with this situation and formulating recommendations for legal solutions to better deal with similar situations in the future.

* 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: Małgorzata Gerjatowicz-Osmańska, MD, MBA, director of Pratia MCM Kraków, Innovation & Development Team Lead, photo: Pratia press materials

Author: Kamila Śnieżek

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