Every drug available today, even „ordinary” painkillers, which we can buy without a prescription in a pharmacy or store, had to undergo clinical trials. Anna Jakubiec, the head of the nursing department and coordinating nurse at Pratia MCM Medical Center in Krakow tells us about the role of clinical research, development of medicine and harmful stereotypes.
Have you linked your professional career to clinical trials since the beginning?
I have been working in the profession for 11 years, but initially, after graduating from undergraduate studies, I worked in a hospital in the intensive care unit of cardiac surgery. When I finished my master’s degree, I started to look for an additional job and came across a job advertisement in clinical trials. What was initially just an extra job soon became a full-time job. I was absorbed in working on clinical trials and I wanted to develop further in this direction. The first edition of postgraduate studies at the Jagiellonian University „Clinical research – methodology, organization and management” has just started, I signed up for it so I could develop theoretical knowledge and combine it with the experience gained at the center.
Let’s explain what are clinical trials in more detail
Each new drug and each new form of therapy must undergo tests confirming the patient’s safety and effectiveness. This order – first „safety” and then „effectiveness” is crucial, because in clinical research the patient’s well-being overrides science. If we have a drug and want it to be used in treatment, then we need to check its effects or correlations in different treatment lines and this stage is called clinical trials.
From my perspective, clinical research enables patients to heal – often those patients who have already exhausted other treatment options. This is real help for them.
So clinical trials are human studies?
Yes, but the expression „human medicine research” sounds sensational and thus distorts the idea of research. I think we should build awareness of what clinical trials are, because many people get the wrong idea, combining it with „placebo” and „experiment.” That is why I have to explain to patients that even though there are different phases of clinical trials and medicines, which are already registered and used successfully in the treatment of a specific disease in other countries, they still must undergo clinical trials in Poland as well to be approved for treatment in our country. Sometimes the medicine is used to treat one disease, e.g. hypertension, but it also proves beneficial for another disease. However, it cannot be used to treat this second condition unless it successfully passes clinical trials. Also, the introduction of generic medicines (i.e. substitutes for original medicines for which the patent protection period has expired or no one has applied for it) also requires conducting clinical trials.
However, let me remind you – clinical research must confirm safety and effectiveness, but the most important thing in this process is patient safety and protection of their rights.
At the MCM Pratia Medical Center in Krakow where you work, specialist and hemato-oncological trials are conducted. Tell me about this research, please.
The story of clinical research is actually a story of people. In the specialist research department we have dermatology, rheumatology, orthopedics, nephrology, neurology and many others. There are also young and professionally active patients, whose quality of life is significantly reduced due to the disease. By participating in the study, these people can regain the comfort of living. Patients often allow themselves to be honest with us and tell us how, for example, psoriasis affects their lives, about the stigma they are subjected to. And patients with rheumatoid or psoriatic arthritis tell us about the difficulty of performing ordinary activities such as button fastening. Only by talking to the people who are sick can we know the true face of these diseases. That is why I know how important clinical research is for this group of patients.
The hemato-oncological department is the other field of our activity. We look after patients who require special care and sensitivity. Regardless of whether they are people who have recently received a diagnosis or patients who reach us after several treatment lines, we see how important it is for them that we offer them access to treatment.
And are the patients participating in the research also aware of their participation in the development of medicine?
First, they come to us looking for a method of treatment for themselves, and when they are our patients they say that they hope that in the future other patients will be able to receive this drug faster, that they hope that it will be available to everyone. They are aware that they are involved in a process that gives others a chance and opens the way for a new therapy.
Has any event from your professional life got particularly stuck in your memory?
We had a study for hemato-oncological patients in the transformation of the disease. This is a study for patients for whom standard therapies have already been exhausted of treatment options. A patient who was already in serious condition came to us for this examination. This patient decided to participate in the trial and is still one of our patients. Every time I see him, I smile at him but also to myself, because I remember him a few years ago and see him now. And what a difference a few years makes! That is why I know that working in a clinical research center, my efforts, my colleagues hard work is not in vain. Procedures, restrictions, dozens of laboratories to which you need to send samples, things to remember – this effort, because clinical research is also a lot of duties on the side of medical staff – all of that is forgotten when you see such situations.
How did the epidemic affect your work and your sense of patient safety?
Our most important task was and is to maintain the possibility of treating patients, and this was only possible if patients were provided with full safety. That is why, apart from carrying out our daily duties, we introduced meetings every day where we worked on securing patients – we looked for new solutions, checked all Chief Sanitary Inspectorate of the Ministry of Health recommendations, worked out procedures, exchanged information, delegated tasks to perform, etc. We changed the rules of organizing visits. To protect our patients and staff, we launched a special airlock in our center – the patient who was coming to the center just entered the airlock, filled in a questionnaire there, we measured their body temperature, and they received a face mask. After excluding symptoms indicating a risk of infection, the patient could enter the center for an appointment. If any symptoms aroused our concern then the patient had a swab for PCR. They were told to return home and the next day after receiving a negative result, they were invited back for a visit. Fortunately, all our patients had negative SARS-Cov-2 test results. This also required special staff training and additional personal protective equipment. My team met the challenge posed by the epidemic. In this difficult time, however, for us nurses, the patient’s smile for all our efforts is information enough that we are following the right path.
We have introduced intervals between patients – currently we arrange visits on a rotational basis, and in the waiting room patients can no longer sit close together. All for their safety. Our staff is also protected by personal protective equipment. Patients have appreciated our actions – we know that they did feel and continue to feel safe with us.
It had to be a challenge. I remember the beginning of the epidemic – there were mask shortages, recommendations changed often…
I must admit that it was a difficult time – developing and implementing all procedures, developing crisis scenarios, obtaining personal protective equipment required the involvement of all employees of the center. What is more, is that we were constantly looking for more safeguards, we did not stop at introducing the recommended ones, but we sought additional ones, i.e. the above-mentioned transport of medicines to the patient’s home. We have also introduced a rotational system of staff work – if a sick patient appeared in the center, the personnel in contact with him would be quarantined and replaced by an „emergency” team. Of course, the teams didn’t have contact with one another. We did not suspend any trials despite the fact that the nursing team worked in a reduced team in connection with the rotational work and the need to look after their children after school closures.
Let’s return to the role of a nurse in clinical trials – tell me if nurses need to undergo additional training? I was also interested in more details regarding the position of coordinating nurse in Pratia MCM Kraków. Can you expand on this topic?
Nurses working in our center are people with extensive experience who regularly train. We have both full-time nurses at our center and those for whom working on clinical trials is an additional occupation. For me, as a manager of a nursing team, it is extremely important that new people who come to work for us are initially looked after by the person who introduces them into their work and procedures. Our nurses undergo training in Good Clinical Practice (GCP) and Transport of laboratory samples under certain conditions (IATA). Only after this kind of training can we talk about the transition to the next stage – familiarizing with clinical research and procedures.
The coordinating nurse at MCM Pratia coordinates the research and activities related to performing tests from the nursing side, e.g. prepares all necessary things and accessories for the initiation visit (laboratory sets, shipping information, equipment, certificates). In addition, she is responsible for medical nursing documentation, i.e. information about the laboratory, how to handle samples taken from the patient. The coordinating nurse knows the protocol best of the whole team, she is an expert in a given study – and also a support in this study for other nurses. She also takes part in audits and inspections representing the center before the sponsor. In addition, the coordinating nurse is responsible for training the team for a given study. She cooperates with a team of coordinators and pharmacists in the preparation of documents necessary to conduct visits according to the protocol.
What kind of clinical trials are you conducting at Pratia centers?
We have eight Pratia centers throughout Poland. Each of the centers has been successful in conducting both population studies such as influenza, RA [Rheumatoid arthritis], AD [Atopic dermatitis], Psoriatic Arthritis, chronic cough, acne, diabetes, hypertension, as well as difficult diseases in the field of oncology, hematooncology, and gastrology.