The Czech Republic boasts a solid clinical research infrastructure and a supportive regulatory environment, meaning that it stands out as one of Central and Eastern Europe’s top destinations for clinical trials. However, a decline in the number of clinical trials in recent years means that Czech stakeholders are looking to find niches in which it can excel to continue its tradition of excellence.
A Tradition of Excellence
As Darina Hrdličková, chairwoman of the Association of Contract Research Organizations in the Czech Republic (ACRO-CZ) explains, the Czech universal healthcare system, first created under socialism, is conducive to patient enrolment in clinical trials. “Each healthcare structure, such as public hospitals or groups of state-owned outpatient clinics, has a catchment area, which makes it easier to find and enrol patients in clinical trials.” After the Velvet Revolution of 1989, the country went on to construct Specialised Centres for patients with a specific diagnosis.
We have state of the art equipment, hospitals, and doctors already in place, so there is great potential in clinical research in this region
Although a small country of only ten million citizens, there are ten medical faculties in six different universities across the country. Some of the most well-known include the Institute of Clinical and Experimental Medicine (IKEM) in Prague and the Masaryk Memorial Cancer Institute (MMCI) in Brno, in addition to other university hospitals joined to medical schools.
As Petr Vaculík, country manager of PSI CRO points out, “We have state of the art equipment, hospitals, and doctors already in place, so there is great potential in clinical research in this region.” He continues, “the Czech Republic is highly competitive in terms of patient recruitment. We have some of the highest numbers of patients in clinical trials per total number of patients in the CEE Region.”
Syneos Health Czech Republic’s medical director, medical management and scientific services Olga Starobová adds that these sites “all have a deep understanding of Good Clinical Practices provided by the International Conference on Harmonization (ICH-GCP). Some even have their own standard operating procedures.”
Moreover, Starobová points out that“they are good at recruitment and can capitalize on the large Czech patient pool to produce quality and reliable data, which is always important for any clinical trial.” Because of this, Syneos Health has been able to build up a strong local footprint and is present in around 35 percent of all clinical trials ongoing in the Czech Republic.
Challenging Times
Challenges to the Czech Republic’s continued positioning as a leading regional clinical trial destination include an ongoing shift in patient populations. As PSI CRO’s Vaculík asserts, “we are in a period of change,” with many patients with diabetes and cardiovascular diseases leaving the country. “This means the Czech Republic can no longer compete with other bigger Eastern countries, such as Ukraine or Russia, or with many smaller countries for trials in infectious diseases,” he explains. Other challenges include the increasing costs of conducting clinical trials locally, with the Czech Republic now on a par with South-Western European countries such as Spain and Portugal costs-wise.
With such high price pressures, sponsors have no incentive to conduct clinical trials here
Over the past decade, the number of clinical trials approved by the Czech regulatory body, the State Institute for Drug Control (SUKL) has been on a slow downward trajectory, going from a peak of 313 in 2012 to 275 in 2018. As of November 2019, the SUKL had approved only 194 trials. “The reason for the decline possibly lies in the fact that pharmaceutical companies prefer to conduct trials in larger markets such as France, Germany, and Spain where volumes and prices are more attractive” comments ACRO-CZ’s Hrdličková, adding that “with such high price pressures, sponsors have no incentive to conduct clinical trials here.”
Stakeholder Support
Despite this decline in overall numbers, the country can still attract high-quality trials, thanks in large part to a supportive regulatory environment. SUKL, often described as “strict but fair” is renowned for prioritizing patient safety. Nevertheless, there are no delays in clinical trial application approvals; all are given within the 60 days guideline. “I believe SUKL is extremely cooperative, fast, and direct in their decisions,” claims Syneos Health’s Starobová. “I feel extremely thankful towards [SUKL],” exclaims Hrdličková, noting that the regulator is particularly proactive and open to change.
I believe SUKL is extremely cooperative, fast, and direct in their decisions
However, as Vaculík urges, “We urgently need help from government authorities, particularly the Minister of Health, when it comes to organizing contractual processes.” Pavla Rozmarová, clinical research associate manager & regional OD for Scope International, agrees, noting that an update to the country’s relatively old laws and regulations is urgently needed. “All the key stakeholders, from the government to SUKL and members of the main industry associations can influence a change in the clinical research landscape,” she emphasizes.
This is exactly the direction in which Hrdličková is taking ACRO-CZ, recently partnering with the Association of Innovative Pharmaceutical Industry (AIFP) to create joint educational activities. “One of the focuses of our association is education, not only towards physicians but for all healthcare professionals.”
Niche-busting
Although clinical trials in cardiovascular and diabetes are moving out of the Czech Republic, the country is differentiating itself from its neighbours as the perfect location for trials in more niche areas such as cell and gene therapies, cannabinoids, and rare diseases. “These innovative therapies are the future of research and treatment” proclaims Starobová, adding “we are already being requested as a site for these trials which is a fantastic sign.”
[Becoming a top recruiter for autologous transplantation of human cartilage trials] was a challenge, but we were able to develop this know-how which is something we at Scope are proud of
Scope International has had the opportunity to work on Advanced Therapy Medicinal Product (ATMP) studies, performing several Phase I trials in this area. Focused on monitoring and site management, Rozmarová reveals that together with the Czech investigators, Scope International was a top recruiter for autologous transplantation of human cartilage trials. “It was a challenge, but we were able to develop this know-how which is something we at Scope are proud of.”
If the Czech Republic continues to identify clinical trial niches in which it can excel, the future looks bright. PSI CRO’s Vaculík aims to continue supporting and providing more services for the firm’s global operations, adding “there is huge potential for us to make an impact in the region.”
Syneos Health’s Starobová is looking forward to working with companies of all sizes, “that we can mold our Biopharmaceutical Acceleration Model (BAM) well too”. With a long road ahead of adapting and shaping the local landscape, it is evident that the key stakeholders are pulling together to ensure the Czech Republic is a top destination for clinical trials, ensuring that “no patient is left behind”, concludes Hrdličková.
