Vaccine Clinical Trials are not a challenge – interview with Anita Szczęsna

For Pratia, vaccine Clinical Trials are not a challenge

So far, we have conducted over 75 Clinical Trials in this therapeutic area. Thanks to our 34 research sites in 6 European countries, Patients and Sponsors have access to the most qualified medical staff, including 55 Principal Investigators specializing in vaccines and 125 Co-Investigators. This is an advantage that hardly anyone has. On our platform, Poland leads the way in vaccine-related Clinical Trials. We talked with Anita Szczęsna – Regional Director for North-West Poland, about the challenges faced by Sponsors as part of Clinical Research in this therapeutic area and how Polish research sites within the Pratia platform can respond to these challenges.

Pratia: Poland leads the way regarding the number of Clinical Trials in vaccines. The average percentage of Patients included in these Clinical Trials is from 100 to 150% of the target set in the contract. What is the reason behind this success?

Anita Szczęsna: I think that the main reason for our success is that we cooperate with a very experienced and aware medical team, who support vaccination prophylaxis, know their Patients well, and understand what vaccination needs are for specific groups of the population. In addition, they understand the need to research more effective and safer therapies so that they can talk to their Patients. Those who wish to participate in a Clinical Trial inform about the possibilities of participating in vaccine Trials.
For our Sponsors and us, the Trials must be conducted within a target population. Hence it is essential to identify and encourage this population to participate in the Clinical Trial. We work with Doctors who are not only on the research team (Investigator and Sub-Investigator) but also with those who appreciate the development of medicine thanks to Clinical Research. Together we spread the news to raise awareness about the importance of Clinical Trials in the development of medicine.

Pratia: Medical team is a broad term. Tell us about the people behind the Party's success in Clinical Research.

Anita Szczęsna: The team consists of Doctors, Nurses, Coordinators, and Pharmacists, as well as different medical professionals who enjoy a great deal of trust in their local communities. The Medical Team is prepared methodologically, thanks to various training and vaccination courses. They have experience and scientific knowledge and are capable of providing assistance in case of an emergency. In other words, they are focused on the well-being of the Patients.
The Doctors we work with have extensive and many years of experience in vaccinations, not only within Clinical Trials. They have arguments to educate Patients in a simple and understandable language. Our Doctors are up to date with the latest reports, guidelines, and knowledge on the latest therapies so that they can share this knowledge with their Patients.
I think it is also worth mentioning the significant role of our Nursing team in recruiting Patients. Our nurses enjoy tremendous social trust and have good contact with Patients. This fact positively translates into Patients' interest in Clinical Trials, and Patients are willing to contact Pratia to talk about them. This gives us access to the patient population from various backgrounds and geographical areas.

Pratia: What are the challenges that Sponsors face?

Anita Szczęsna: Each Clinical Trial program involves recruiting a specific group of Patients so that the collected medical data is reliable, statistically significant, and assumed in a given Clinical Trial plan. Thanks to the merits and preparation of our Research Team, access to Patients gives us an excellent chance for success in recruiting Patients.
It is worth mentioning here the high retention of Patients in this Research, which is also associated with the experience and preparation of the Research Team and their trust in local Patient communities. Thanks to the confidence and substantive practice of Doctors and Nurses, as well as their honesty based on knowledge and facts with the Patient about participation in a Clinical Trial, the dropout rate is very low. We are always looking for Patients convinced about participating in Clinical Trials and who consciously participate in them. This is our key to success.
Another challenge faced by Sponsors is the timing of the vaccine administration. However, many of these Studies are seasonal immunization programs. CRO representatives and Research Sites must meet specific requirements, send start-up documentation on time, conduct training of the research team, and think about the start of the research much earlier. In seasonal Vaccine Studies, recruitment to a given Study is possible only for a specific period.

Pratia: Seasonality in Vaccine Research plays a significant role and impacts Patient dropout rate or recruitment success. And how is it with the vaccination schedule carried out by the Ministry of Health or local governments? Does it influence recruitment success?

Anita Szczęsna: I would not combine vaccination as part of Clinical Trials with vaccinations as part of preventive programs. Clinical Trials in vaccines are aimed at finding modern therapeutic or prophylactic options. Medicine is constantly evolving. Clinical trials are used to find vaccines that, for example, have lower adverse postvaccination reactions or have a prolonged effect.
As for the flu, in Poland, vaccination against this disease is reimbursed for seniors and people with comorbidities. Overall, reimbursement options are minimal, and Clinical Trials might also be an opportunity for Patients to have access to investigational vaccination.

Pratia: What are the other challenges for Patients? How can Clinical Trials meet these challenges?

Anita Szczęsna: The role of Clinical Trials is to confirm the effectiveness and safety of drugs, vaccines, and medical products on the market in a specific group of Patients. The Sponsors are researching to find new molecules that can constitute a modern and effective therapeutic alternative for Patients in treatment and prevention.
We are currently in the Covid -19 pandemic, at the stage of implementing new vaccines based on mRNA technology, thanks to which we can begin to move away from older types of vector vaccines.

Pratia: Vaccines are … (definition for Patients). 

Anita Szczęsna: For me, vaccines mean prevention. It is always better to prevent a disease than to treat it later, so prevention is essential. Doctors, whose task is also prevention, tell us that the elderly should get vaccinated against the flu so as not to infect their grandchildren, children whom they often care of.
Moreover, the elderly should also get vaccinated prophylactically so that they do not get infected by the children they care for returning from kindergarten and school. For the elderly population, respiratory diseases can be a severe threat with serious health consequences.
Our Doctors give these solid arguments about vaccination, whether Clinical Trials or standard prophylactic vaccinations. These arguments reach the Patients, and I think it is also a target element that allows us to encourage, recruit and increase the retention of these Patients to the Research.

Pratia: How is vaccination coverage in Poland? 

Anita Szczęsna: Influenza vaccination coverage in Poland is low compared to Western Europe. Also, I think a lot of work still is to be done ahead of us. Unfortunately, vaccination coverage in Poland is decreasing. For example, I recently read that the vaccination coverage for measles has dropped to 85% and is already the limit, and 90% of the population must be vaccinated to feel safe as a society.
There are also supporters of vaccination in our society. I am talking here primarily about the parents of children who make sure that their children are vaccinated according to the vaccination schedule. There is a significant role here on the part of the clinic, which usually phones Patients and reminds them of vaccination. Overall medical institutions are very well organized in Poland. I am speaking here from the mother's perspective, who vaccinates her children according to the immunization schedule.
However, we should not forget that there are also people who, unfortunately, appear more often and give up vaccinations altogether.

Pratia: In which diseases, in terms of vaccinations, do we have experience, and what can we be proud of in Poland?

Anita Szczęsna:

As for the Vaccine Clinical Trial programs that we have carried out or are currently available, these are:

• Meningococcus,

• Pneumococci,

• Flu,

• HPV,

• RSV.

We have already mentioned flu vaccinations. We have experience in Clinical Trials in all age groups from 6 months to 85 years of age. In a multi-site international Clinical Trial, we became Poland's TOP recruiter by including the most significant number of Patients in the Trial.

We have also experience with meningococci in the group of children and adolescents. We have extensive experience in including Patients and Parents willing to vaccinate their children to participate in Clinical Trial programs. We have implemented projects for international Sponsors, meeting the original assumptions regarding the number of Patients enrolled and demonstrating the high quality of the collected medical data.

Another good case is the vaccination against Pneumococcus in people with chronic diseases. It was a big challenge. It was not so easy to find the right group of Patients with different comorbidities, such as asthma, heart failure, congenital heart defects, and smoking. In this study, we were the world's top recruiter: over 50 Patients from 1 Site.

What was the reason for this success? We approached the topic interdisciplinary, i.e., we included Doctors from various specializations in the research team: cardiologists, pulmonologists, internists, and hepatologists. Thanks to this collaboration, we could have included Patients in this Clinical Trial.

It was challenging to recruit Patients with congenital heart defects. Patients whom we recruited constituted approx. 50% of all Patients who were included in the program in all the Sites. For the Sponsor, it is both a quantitative and qualitative success. First, finding Patients with complex disease entities who would like to participate in a Clinical Trial is undoubtedly challenging. We owe our success to our research team and Doctors of various specialities.

We are preparing for a Clinical Trial of the RSV vaccine in the adult population. RSV is a disease that is generally most commonly diagnosed in young children. Premature babies are currently vaccinated for RSV, and Doctors are aware of this. However, I think a group of older people with multiple comorbidities would also be very interested in getting an RSV vaccination. There is no social need, and this is an unknown disease. It is a tremendous substantive and medical effort of Doctors to show Patients how dangerous this disease is.

We cooperate with pulmonologists who have contact with elderly Patients with asthma and COPD and believe that vaccination with RSV is a valuable therapeutic option.

Pratia: Interesting; what else do you offer? 

Anita Szczęsna: We are preparing to start a Clinical Trial program with the HPV vaccine for young women. Prevention in this area is already being implemented in medical facilities in Poland. Public awareness is high, and there will be no problems recruiting Patients for this Clinical Research project.

We are happy to undertake a Clinical Trial project for the Lyme disease vaccine. There is a great need due to the increasing number of cases of Lyme disease in our country, and General Practitioners are also waiting for them. Awareness in Poland about Lyme disease is very high. Pratia in Poland, with its commitment and qualified medical team, in multidisciplinary disease entities, as part of vaccination programs, is ready for this challenge.

We invite sponsors and CROs to cooperate with the network of Pratia Polska Sites, which will be willing to participate in vaccination research. As you can see, we have interdisciplinary experience in this therapeutic area. From Bydgoszcz (which has a lot of experience) to our newest acquisitions – Jelenia Góra and Chojnice, we can offer our Partners and Patients access to the best Doctors, Nurses, and other Representatives of the research team who know about Clinical Trials and can see the challenges with which they are struggling.