European clinical trial guidelines meant to make trials safer and more efficient are actually slowing down studies that could help patients, and even dissuading researchers from launching trials at all, according to an opinion published online today (November 16) in PLoS Medicine.

Image: Wikimedia commons, S. Solberg J.

The European Union's Clinical Trials Directive, adopted in 2004, says that trials evaluating investigational medicinal products should follow Good Clinical Practice (GCP), an international quality standard for human clinical trials. According to Alex McMahon of the University of Glasgow in Scotland and his colleagues, who wrote the opinion piece, the stringent definition of GCP employed in the Directive makes sense for trials sponsored by biopharma companies, which are generally developing new medicines, but not for trials run by academic medical centers, which more often are studying already-licensed drugs in order to fine-tune their use in the clinic.

Although the regulatory suggestions outlined in the Directive are not legally binding in most EU countries, the authors write, academic centers and regulatory agencies are needlessly enforcing them, and this over-interpretation of the rules is dramatically slowing academic clinical work.

"Since the legislation, the approval [process for clinical trials] has magnified several-fold in terms of [effort] and length of time," said Morris Brown, a professor of clinical pharmacology at the University of Cambridge, UK, who wasn't an author on the opinion. The Directive "makes it very difficult for anyone but the most determined person to get the research started."

Getting a trial going now involves approval not just from an ethics committee, but often from "research and development" departments cropping up at universities, said Brown, who wrote about the issue last year in the British Medical Journal. He added that the ethics submission has grown from just a few pages to an 80-page document, requiring extensive detail on such issues as informed consent, reporting of adverse events, and national inspection of trials. While these issues are important, they were satisfied under the old system in a much more efficient manner, he said.

The increased paperwork is dragging out the time needed to get trial protocols approved, he said. While it used to take just a few months to get a clinical trial up and running, it can now take more than a year. Furthermore, he added, "younger investigators are put off from even starting on the project."

According to McMahon and his colleagues, European regulators need to recognize this problem and adjust accordingly. In addition, they write, "other parts of the world should learn a lesson from the misguided trial regulation that have been created in Europe."


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[23rd October 2000]