Denmark’s and Spain’s strong performance in clinical drug trials is inspiring other EU members to adopt similar models. Denmark is now advancing to develop more flexible, decentralised trials for patients.
There is a general decline in clinical trials in Europe, according to the recent IQVIA report commissioned by EFPIA and Vaccines Europe. All but three EEA countries (Slovakia, Portugal, and Greece) saw a fall in the absolute number of new clinical trial starts in 2023 compared to 2018.
Still worse, clinical trials also declined in key areas such as oncology, neurology, rare diseases, immunisation and paediatric trials.
On the other side, Denmark and Spain have experienced an increase in trials over the last five years, according to the report.
At the same time, countries like Sweden and Belgium are trying to counter this loss of clinical research through new investments inspired by Denmark’s and Spain’s strong models.
Denmark currently has the highest number of clinical trials per capita, followed by Belgium, while Spain’s advantages, such as a high-quality healthcare system, have made the country attractive to investors.
Both EU members have a proactive approach, adopting supportive policies early on, initiating strong collaboration between commercial and non-commercial stakeholders, and establishing centres and networks across the countries to facilitate clinical research.
Belgium, second best in the EU
This model is also inspiring Belgium, especially the strong performance of Spain, the Belgian Association pharma.be told Euractiv.
Despite a significant reduction in immunisation research in Belgium, the country remains at the top per capita in Europe, after Denmark.
In 2022, Belgian authorities approved 474 clinical trials, with the largest proportion for oncology trials. This is largely due to biopharmaceutical companies, which account for about 80% of clinical study applications in Belgium and benefit from a solid ecosystem of high-quality academic institutions, well-developed hospitals and research centres, and knowledgeable authorities.
“It is crucial to provide a structured response to maintain Belgium’s attractiveness. This should involve all stakeholders in clinical research to ensure a harmonised, flexible, and facilitating ecosystem for clinical trials,” pharma.be said.
According to the association, forthcoming efforts should focus on, for example, increasing trial capacity, improving infrastructure, and reducing bottlenecks by better preparing research centres and addressing staffing limitations.
Additionally, implementing new, patient-centred methodologies for clinical trials would be essential to enhance execution efficiency and increase patient appeal,” said a pharma.be representative.
Denmark’s long-standing joint efforts
“In Denmark, the most important success factor has been a long-standing shared political awareness of the value of having strong clinical research,“ Jakob Bjerg Larsen, Head of Clinical Trials and Pharmaceutical Manufacturing Policy at the Danish Association of the Pharmaceutical Industry, LIF, told Euractiv,
In addition, Denmark has a substantial, high proportion of non-commercial investment in clinical trials, as the government has supported the clinical research environment for years.
According to the IQVIA report, the public share has been around 40 per cent per year from 2013 to 2023, compared to the EU average share of around 25 per cent.
“Both the commercial and hospital-led research benefit from this policy, as well as the non-commercial investment and activities, strengthen the entire clinical trial ecosystem,” said Bjerg Larsen.
In 2018, the well-known Danish partnership called Trial Nation was set up to offer an entry point not only for life sciences companies but also for patient organisations and clinical researchers who wanted to sponsor, participate in, or conduct clinical trials.
Denmark’s lead
“In Denmark, they have been working strategically and long-term with this focal point, which facilitates new clinical trials,” Jenni Nordborg, Director of International Affairs at the Swedish Association of the Pharmaceutical Industry, LIF, told Euractiv.
This model has motivated Sweden, where the number of clinical trials has been falling for a decade, with 2023 being a record-low year. Norway and Finland are also said to be working in the same direction as Denmark.
“A national partnership, SweTrial, is finally underway as the government has commissioned the Medical Products Agency to set up a structure. It will provide a clear structure for collaboration between healthcare, industry and academia,” Nordborg remarked.
Leading the project for the establishment of this hub, Peter Asplund of the Swedish Medical Agency told Euractiv that the state investment for SweTrial is proposed to reach € 2,6 million in 2025 and then double at € 5,2 million per year starting from 2026 to support the healthcare system’s capacity to increase clinical trials.
“We are now preparing an appropriate organisation and engaging with stakeholders in setting up a national partnership and hub, enabling an increase in clinical trial capacity in Sweden and improving patients’ access to new medicines. A key step in strengthening the life science sector in Sweden,” he said.
Meanwhile, the exact organisational model will not be announced until February.
Decentralisation, the way forward
At the same time, the Trial Nation partnership, now six years old, is working to provide stakeholders with a framework for performing quality decentralised clinical study (DCT) designs to promote the use of DCTs, said Michelle Rosgaard Birknow, Head of Decentralised Clinical Trials Development at the Trial Nation.
“We want to make sure that we continue to attract clinical research to Denmark and that Danish patients get the best treatments available,” she added.
However, there are currently many different definitions of DCTs in Denmark and internationally.
The Trial Nation’s perspective is that DCTs exist as a spectrum. “It is not all or nothing,” she stressed. They entail not only fully decentralised clinical trials but also clinical trials using a few decentralised elements (hybrid trials).
“For me, it is all about offering patients more flexibility in clinical trials and changing the way we work. For example, introducing elements such as allowing for patients to stay at home more, using digital technology or dispensing trial drugs at a pharmacy close to the patient,” Rosgaard Birknow said, adding that “the choice is important – because no one is the same.”
[Edited by Vasiliki Angouridi, Brian Maguire]
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Publish date : 2024-11-04 17:14:00
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