Lukasz Wozniak joined the industry in 2005 working for CRO companies. He has been working independently since 2010 as a freelance clinical trial consultant contracted by pharmaceutical and CRO companies covering CRA and regulatory affairs positions. Overall, Lukasz has 16 years of experience in research and in recent years, he has joined our country advisors network (CAN) helping industry professionals gain insight into Poland’s research landscape.
If you are interested in conducting a clinical trial in Poland, here is what Lukasz shared about the state of affairs in the last 2 years.
Excellent recruitment capabilities
According to Lukasz, who often gets questions from recruitment companies about potential recruitment figures, Poland’s large population is one of the things that aid recruitment. Among the benefits of conducting a trial in Poland are also the country’s sites and investigators. Investigators are motivated and well-educated medical specialists and there is a growing network of sites that specialize in research that provide quick startup timelines, good quality, and performance.
Lukasz points out that over the years the Polish clinical research industry has developed a lot and now it is on par with the leaders in clinical research. As the number of studies conducted in Poland is growing, last year the Polish Competent Authority has registered a record number of new clinical studies coming close to 700 projects.
In Oncology, for example, Poland ranks second place vs countries like the UK, France, Germany and Belguim based on Competition, Past experience, Recruitment rates, Startup timelines and Covid-19 impact combined.
Poland ranks even higher when we filter for single-country trials on TrialHub. If you’d like to know more, you can get in touch with our analysts.
Recruitment in Poland is also boosted by relatively high clinical trial awareness among patients, especially those living with rare diseases or cancer. Lukasz explains that the Polish healthcare system is far from perfect therefore for many patients participating in a clinical trial is a chance not only to receive promising treatment but also to get better medical care.
Patient awareness is also promoted by investigator sites as well as advertisements (radio, internet, brochures) about clinical studies. Some sites also organize check-ups for the patient to develop their patient databases.
A lot of Oncology studies conducted in Poland
Lukasz notes that Poland is well known among Sponsors and CROs as a country with good recruitment and good quality data produced. This is why most therapeutic areas are represented in the Polish clinical research landscape. However, one area that pops out is Oncology.
Oncology trials are a chance for patients to receive innovative treatment options and with quite a few very large oncology centers in the country, recruitment figures usually stand out from the average. Indeed, when it comes to Oncology Eastern European countries seem to recruit better and Poland shows pretty high numbers – this is for single indication treatment trials in the TA.
All study phases are conducted including phase I projects as well as post-marketing phase IV studies.
The high recruitment rates in the TA could be due to the standard of Oncology care in Poland and the state of drug reimbursement. If you’d like to learn more about Poland’s standard of care, reimbursed drugs, and the patient journey, you can reach out and we’ll support you with TrialHub’s capabilities.
On the other hand, a lot of Oncology research in the country could translate to higher levels of competition. If you’d like to know how much competition you would face for your trial in Poland, you can check out on TrialHub or ask one of our analysts.
Would you like to avoid competition? You can try exploring research-naive sites recommended by our country advisors.
DCTs are slowly coming to Poland
“Decentralized Clinical Trials are slowly coming to Poland but the regulations are not up to date with DCT requirements”, said Lukasz.
Polish Competent Authority has acknowledged the changing environment and the changing requirements but mostly with respect to the current situation following the EU Guidance on the Management of Clinical Trials during the COVID-19 pandemic.
The key recommendations of the updated guideline relate to the management of the clinical trial (for example home visits, transport of the investigational medicinal product directly to the participant, remote SDV). With respect to the regulations that need to be updated to allow the DCT conduct are the rules of signing the informed consent remotely (currently patient signature is required) and remote access to the source data (currently the access is allowed only at the study site).
If you’d like to know which DCT modalities you are allowed to use in Poland, you can check out our DCT Regulations 2022 Report.
With regards to decentralized trials in Poland, the pandemic was a huge accelerator. Although in the beginning, many trials were put on pause, especially those conducted in general or university hospitals, which experienced a lot of restrictions, the industry found a way to continue supporting patients.
“In general, sites have adjusted quite quickly to the new reality implementing necessary safety measures to enable patients to continue participation and monitors to do their work. Currently, I do not observe any major impact of the pandemic on clinical trials performance in Poland”, said Lukasz.
Patients are open to DCT solutions
Lukasz notes that in some of the studies he was involved in, home nursing was well-received by patients. It was also helpful to the study sites in managing patients, especially during pandemic times as some patients needed to travel long distances for site visits.
“The doctors and investigators also got used to performing the visits and assessments remotely with the use of electronic communication means. Direct to patient IMP shipments are also becoming more and more popular,” said Lukasz.
What helps accelerate decentralization in Poland, in his view, is the fact that a lot of sites are specialized in conducting clinical trials (SMOs and site networks). They are ready to adjust to new and innovative ways to conduct and manage studies.
Patients, in his experience, are quite welcome to new technologies and solutions as long as they make their lives and clinical trial participation easier.
And when it comes to those, Lukasz notes that the home nursing network, in particular, is quite developed with a few global vendors providing services within Poland. There is also a growing number of local vendors developing a network of GCP-trained providers (nurses, physicians) who are involved in supporting studies in various therapeutic areas by conducting home care visits.
If you are considering conducting clinical trials in Poland, our feasibility platform TrialHub can support you with data and insights about recruitment rates, competition, drug reimbursement, standard of care and more. You can also find Lukasz Wozniak on LinkedIn.