The number of new trials is down by nearly half since the launch of new rules.
The number of large clinical trials across Europe is drastically down a year after new rules on clinical research went into effect, according to a study presented in early November. The rules, meant to promote Europe-wide research, might instead force scientists to limit their trials to a single country, experts caution.
It is especially frustrating for the lone academic investigator wishing to launch a multicenter trial. Norman Williams, University College London
National regulations on clinical research vary widely across Europe. The European Union Clinical Trials Directive, launched in May 2004, was intended to simplify the rules and establish a Europe-wide model for both academic and industry-sponsored trials (Nat. Med. 9, 1336; 2003). But since its launch, scientists have warned that the onerous new requirements and added paperwork and costs would hamper trials by academic scientists.
The number of Europe-wide trials submitted for research grants or ethical review has dropped 30–50% since the directive's launch, according to data from research institutes and funding agencies. The proportion of noncommercial trials has also declined from 40% to 14%. “Overall, Europe is witnessing a very negative consequence of the European directive,” says Jaap Verweij, an oncologist at Erasmus University in Rotterdam.
The researchers chose eight countries, including the UK, France and Italy, based on their capacity to fund academic research, particularly in cancer, and the size of their population. The researchers assessed how each nation revised its laws to comply with the rules.
Although the directive harmonized some matters such as the time frame for authorizing new trials, it created significant differences in the ethical review of trials, sponsorship and liability issues, says lead investigator Markus Hartmann. Only four countries thus far have added express provisions for noncommercial trials into their legislation and of those, only Italy and Belgium are fully complying with the directive's requirements for academic research. Hartmann presented the data at the European Cancer Conference in Paris in November.
Ultimately, experts say, the requirements might put an end to Europe-wide multicenter trials and promote more national research projects. “The detail of the directive is being interpreted by each country in a slightly different way, which is especially frustrating for the lone academic investigator wishing to launch a multicenter trial,” says Norman Williams, a clinical trials coordinator at University College London.
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Bosch, X. Europe's restrictive rules strangling clinical research. Nat Med 11, 1260 (2005). https://doi.org/10.1038/nm1205-1260b
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DOI: https://doi.org/10.1038/nm1205-1260b
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