The Netherlands offers high-quality care paired with strong academic centres and a collaborative ecosystem. Still, its main challenge in attracting more clinical trials is execution speed and predictability, says the chairperson of the Dutch Clinical Research Foundation (DCRF), Bart Scheerder.
A recent report by pharma trade group EFPIA highlighted that industry-sponsored clinical trials generate €35.7 billion in economic value across the European Economic Area each year, support 165,000 jobs, and prevent 26.9 million sick days. Yet Europe’s share of global trials has collapsed from 22% in 2013 to 12% in 2023. China’s share more than doubled over the same period, reaching 18% in 2023.
Scheerder told Euractiv that while Europe has made real progress with the Clinical Trials Regulation, sponsors still need faster and more predictable execution across member states.
“In the Dutch National Action Plan for Clinical Research, the benchmark cited is that the average study start-up in the Netherlands is around 200 days, versus around 50 days in some other EU countries,” Scheerder said. “That gap is too large in an international market where sponsors compare countries on speed, simplicity and certainty.”
Dutch clinical trials are declining
Gerrie Spaansen, a spokesperson for the Dutch Innovative Medicines Association (VIG), said the overall number of clinical trials conducted by companies in the Netherlands is on the decline.
“Regulatory and administrative procedures are lengthy, and timelines are often unpredictable. National rules on data use make accessing, using and sharing data complex and inefficient,” Spaansen said. “The costs of clinical studies are high, and patient recruitment can take a long time to complete.”
Spaansen also highlighted that not all innovative medicines are available in the Netherlands due to strict reimbursement policies.
“As a result, the Dutch standard of care does not always align with the international standard of care. This limits the possibilities for conducting comparative clinical research between medicines in development and the treatments that are internationally considered standard,” Spaansen said.
In an effort to shorten timelines and boost predictability, the Netherlands is participating in FAST-EU, a pilot project aiming to accelerate the coordinated assessment and authorisation of multinational clinical trials.
“By joining the pilot, we can already identify any areas for optimising our processes and ensure timely implementation of process changes,” a spokesperson for the Dutch Central Committee on Research Involving Human Subjects (CCMO) told Euractiv.
So far, the Netherlands is involved in five submissions under FAST-EU. In one of these, it is a Reporting Member State (RMS) while serving as one of the Member States Concerned (MSC) in the rest.
Unpredictable supply, rigid timelines
Meanwhile, the CCMO is also dealing with other issues closer to home after an employee survey found the workload was perceived as extremely high. The CCMO’s spokesperson said a working group set up by the health ministry is investigating these concerns.
While saying it is premature to reach conclusions, the spokesperson mentioned that assessing clinical trials combines an unpredictable supply with rigid timelines. This means that the workload is only partially plannable. As the Netherlands receives a relatively high number of requests to act as an RMS, staff often need to balance between battling daily deadlines and contributing to innovations. Industrial and pharmaceutical submissions with medicinal products have actually been on the increase, with 291, 362, and 400 being filed each year between 2023 and 2025.
“A third aspect is that the CCMO staff has rapidly increased since CTIS came into existence and has meanwhile outgrown its management structure,” the spokesperson added.
New information sheet template
The CCMO is actively engaged in several projects aimed at helping companies conduct clinical trials. On May 1st, the CCMO is implementing a six-month trial period for an improved and condensed information sheet for research participants (IRP). The project aims to make life easier for both researchers and participants by offering a legally compliant template. The template will become mandatory following the trial.
The body is also currently helping to draw up a national action plan for clinical research. This year’s focus is on reducing the average study start-up time to 50 days, to promote the involvement of research participants, and to support researchers’ networks.
Reducing the start-up time is needed to attract sponsors who are comparing countries on speed, simplicity, and certainty. In Scheerder’s opinion, the main issue is not scientific quality, but operational friction.
He suggested the Netherlands should focus on using the standard Clinical Trial Agreement without repeated local rewrites, centralise budget negotiations instead of repeating them site by site, and apply national agreements on local feasibility and site suitability more consistently.
A useful point of reference to what the Dutch clinical research system capacity could look like came during the height of the coronavirus pandemic, according to Spaansen.
“During the pandemic, trial activity reached a relatively high level. Rather than stabilising at that level or returning to pre‑Covid levels afterwards, trial numbers have continued to fall,” Spaansen said. “This points to structural issues that go beyond the exceptional circumstances of Covid‑19.”
[VA, BM]
Source:
www.euractiv.com