Despite maintaining a strong position in the European clinical trial landscape, Czechia faces challenges that could undermine its ability to remain competitive. Experts call for systematic support to reverse the negative trend.
A recent analysis by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and IQVIA reveals concerning trends in the global clinical trial ecosystem.
Over the past decade, there has been a marked shift in pharmaceutical research from Europe to other global regions, particularly the United States and Asia. While the global number of research projects has risen by 38%, the share of clinical trials in the European Economic Area (EEA) has halved.
In 2023, pharmaceutical companies conducted only 12% of commercial clinical trials in the EEA, a sharp decline from 22% in 2013. Meanwhile, countries like China have doubled their number of trials over the past five years, capturing 18% of the global market.
This decline is attributed to regulatory inefficiencies and slower approval processes in Europe. These delays are especially problematic for studies conducted across multiple countries, where coordination is essential. In addition, access to larger patient populations in the U.S. and China provides those regions with an advantage in recruiting trial participants.
Czech fragmentation
The Czech Republic remains a strong player in Europe, with 481 clinical trials conducted in 2023, marking a 17% increase compared to 2021. Research predominantly focuses on oncology, immunology, infectious diseases, cardiovascular conditions, and respiratory diseases.
Over 16,000 patients and 2,322 research teams were involved in these trials, with pharmaceutical companies investing CZK 2.1 billion in 2023, an 18.5% increase compared to 2017.
However, experts warn that systemic challenges are hindering further growth. Clinical trial processes in Czechia are fragmented, with each healthcare facility adhering to different rules and guidelines. This lack of standardisation, coupled with significant administrative burdens, often delays the initiation of studies.
“Clinical trials in our country are heavily fragmented – each healthcare facility has its own rules and guidelines, and the administrative burden is enormous. This often slows down the start of studies,” said David Kolář, Executive Director of the Association of Innovative Pharmaceutical Industry (AIFP), to Euractiv.
“If the Czech Republic wants to remain on the map of clinical trials, we need to work on systematically supporting the research environment. This includes strengthening clinical trial departments in healthcare facilities, appointing coordinators, and reducing administrative burdens through digitalisation,” he added.
Government efforts to address challenges
The Czech Health Ministry is taking steps to address these issues. A working group for clinical trials was established in early 2024 to streamline processes and improve support for research teams. The ministry also aims to ensure a sufficient number of qualified study coordinators, whose roles are essential for running clinical trials efficiently.
Health Minister Vlastimil Válek (TOP 09, EPP) emphasised the importance of clinical trials for both patients and the country’s healthcare system.
“We want to do our utmost for our patients, and supporting clinical trials is one of the key ways to achieve this. Thanks to clinical trials, Czech citizens gain access to the most modern treatments. They also provide significant benefits for research teams and enhance the Czech Republic’s representation in global science,” Válek stated in May, when the working group was established.
The ministry’s initiatives are supported by the Large Research Infrastructure CZECRIN. According to CZECRIN’s director, Regina Demlová, the infrastructure has helped Czechia participate in over 30 international non-commercial clinical trials funded by Horizon 2020 and Horizon Europe.
Learning from other regions
Czechia can draw lessons from other successful regions, such as Spain, which has emerged as a major player in clinical research. In 2024, Spain surpassed Germany in the number of newly initiated clinical trials, with annual industrial investments growing by 5.7% over the past decade to reach €834 million in 2022.
Spain’s success is attributed to its healthcare system’s capabilities and effective collaboration between commercial and non-commercial research projects.
To remain competitive, experts agree that Czechia must adopt systematic reforms. This includes standardising processes across healthcare facilities, reducing bureaucratic hurdles, and leveraging digital solutions. Additionally, strengthening the role of study coordinators and enhancing collaboration between institutions will be crucial.
[Edited by Vasiliki Angouridi, Brian Maguire]
Source link : http://www.bing.com/news/apiclick.aspx?ref=FexRss&aid=&tid=674fbb0d47cd4457af6abf6828f4c1c0&url=https%3A%2F%2Fwww.euractiv.com%2Fsection%2Fhealth-consumers%2Fnews%2Ffragmentation-red-tape-threaten-czech-clinical-research-position%2F&c=16105837261760592700&mkt=de-de
Author :
Publish date : 2024-12-03 17:59:00
Copyright for syndicated content belongs to the linked Source.
