A study conducted by investigators across Europe has found that the UK had shorter clinical trial approval and set-up times on average than other European countries.
Focusing on the challenges of delivering multinational clinical trials, the study revealed that the UK improved contract completion times by 97% from pre-Covid (2016-2020) to during the pandemic and after (2020–2023).
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Published in JAMA, the research investigated timelines for ethical, administrative, regulatory and logistical procedures in clinical trials from different countries, including the UK and Netherlands, and discovered a range of hurdles in delivering multinational randomised controlled trials (RCTs) across Europe.
The researchers used data from the Randomised Embedded Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP).
The results showed that the UK achieved dramatic gains in efficiency during the pandemic, with median contract completion time dropping by 97% from 196 days pre-pandemic to just five days during the pandemic. In contrast, other countries in Europe only saw an 18% decrease, from 224 to 183 days.
The study also revealed stark differences in the time to ethical and regulatory approvals. Median time to approval for these in the UK during the pandemic was 8 days, compared to 115 days elsewhere in Europe. Time from approval to first patient enrollment was, on average, three months faster in the UK (26 days versus 116 days).
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By GlobalDataDr Denise van Hout, an epidemiologist at the University Medical Center Utrecht and first author of the paper, said: “These findings highlight the striking differences in research infrastructure and interpretation of regulatory guidelines across Europe.
“For researchers, it is clear that ethical, administrative, regulatory, and logistical processes in Europe can be a major bottleneck to trial initiation and execution, slowing down patient access to potentially life-saving therapies. But addressing these challenges requires proactive efforts, also from researchers themselves.”
Researchers noted that while the UK benefited from its established research networks and emergency trial frameworks, other countries continued to face considerable challenges. The large contract between set-up times shows a real need for harmonisation of set-up procedures across countries.
Van Hout emphasised that, based on this study, researchers who are planning on conducting multinational studies must acknowledge the ethical preparation and contribute to this early. Collaboration between researchers, policymakers, legal experts, and regulators would also assist in developing consistent and transparent processes that prioritise trial delivery while not compromising safety and ethics.
