The Netherlands offers high-quality care coupled with strong academic centers and a collaborative ecosystem. However, its main challenge in attracting more clinical trials is speed of execution and predictability, says the chairman of the Dutch Clinical Research Foundation (DCRF), Bart Scheerder.
One last one REPORT from the pharmaceutical 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. However, Europe’s share of global trials has fallen from 22% in 2013 to 12% in 2023. China’s share has 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 in the Netherlands is around 200 days, compared to around 50 days in some other EU countries,” said Scheerder. “This gap is very large in an international market where sponsors compare countries for speed, simplicity and security.”
Dutch clinical trials are in decline
Gerrie Spaansen, a spokeswoman for the Dutch Association of Innovative Medicine (VIG), said the overall number of clinical trials conducted by companies in the Netherlands is declining.
“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 pointed out 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 match the international standard of care. This limits the possibilities for conducting comparative clinical research between drugs in development and treatments that are considered internationally standard,” Spaansen said.
In an effort to shorten timelines and increase predictability, the Netherlands is participating in FAST-EU, a pilot project aimed at speeding up the coordinated evaluation and authorization of multinational clinical trials.
“By joining the pilot, we can now identify any areas for optimizing our processes and ensure the timely implementation of process changes,” a spokesperson for the Dutch Central Committee for Research Involving Human Subjects (CCMO) told Euractiv.
So far, the Netherlands has been involved in five submissions under FAST-EU. In one of them, it is a Reporting Member State (RMS) while serving as one of the Member States concerned (MSC) in the other.
Unpredictable supply, tight deadlines
Meanwhile, the CCMO is also dealing with other issues closer to home after an employee survey revealed that the workload was perceived to be extremely high. The CCMO spokesman said a task force set up by the health ministry is investigating these concerns.
While saying it is premature to draw conclusions, the spokesperson mentioned that evaluating clinical trials combines an unpredictable supply with rigid timelines. This means that the workload is only partially planned. As the Netherlands receives a relatively high number of requests to act as an RMS, staff often have to balance between fighting daily deadlines and contributing to innovations. Industrial and pharmaceutical drug product filings have actually been on the rise, with 291, 362, and 400 filings each year between 2023 and 2025.
“A third aspect is that CCMO staff has grown rapidly since CTIS was established and has outgrown its management structure,” the spokesperson added.
New information sheet template
CCMO is actively engaged in several projects aimed at helping companies conduct clinical trials. On May 1, the CCMO is implementing a six-month trial period for an improved and condensed information for research participants (IRP). The project aims to make life easier for both researchers and participants by providing a legally compliant model. The template will become mandatory after 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 initiation time to 50 days, to promote the involvement of research participants and to support researcher networks.
Reducing start-up time is necessary to attract sponsors who are comparing sites on speed, simplicity and security. In Scheerder’s view, the main issue is not scientific quality, but operational friction.
He suggested that the Netherlands should focus on using the Standard Clinical Trial Agreement without repeated local rewrites, centralize budget negotiations instead of repeating them page by country, and implement national agreements on local feasibility and country suitability more consistently.
According to Spaansen, a useful benchmark of what the capacity of the Dutch clinical research system might look like came during the height of the coronavirus pandemic.
“During the pandemic, testing activity reached a relatively high level. Rather than stabilizing at that level or then returning to pre-Covid levels, testing numbers have continued to decline,” Spaansen said. “This points to structural issues that go beyond the extraordinary circumstances of Covid-19.”
(VA, BM)
