Some 2,000 clinical researchers have signed an Internet petition calling for changes to proposed new European Union (EU) rules on patient trials. They say that, as the revised rules stand, they would place immense bureaucratic burdens on their backs.

Under the new rules, researchers who conduct clinical trials would have to fill out mountains of forms, follow and report the well-being of patients to a central database, and accept full liability for trials whose responsibility was previously shared among different authorities.

The researchers admit that they have woken up late to the problems posed by the 2001 EU Directive on Clinical Trials, which is due to be implemented through national laws by this May. But they are hopeful that its impact will be curtailed by a more detailed, follow-up directive now being drafted in Brussels, and through the discretion of national governments in passing the laws.

The directive was originally drawn up in the Enterprise Directorate of the European Commission to harmonize the regulation of large clinical trials conducted by the drug industry. But as it developed, its remit was extended to cover all patient trials, including smaller ones conducted by academics involving drugs already on the market.

“All along, there has been too little consultation with those affected by the rules,” says Brian Moulton, a pharmacologist at the Dublin-based Irish Clinical Oncology Research Group, which helped to organize the petition. “But we hope that the extraordinary level of support for our petition will influence policy-makers.”

The directive requires clinical researchers to conform with two detailed sets of EU guidelines, called Good Manufacturing Practice and Good Clinical Practice, and to follow new procedures designed to control the large-scale clinical trials undertaken by drug companies. Scientists hope to relax these obligations by influencing the contents of a subsidiary set of rules on clinical research being drawn up by the commission.

A spokeswoman for the commission says that it is now sensitive to academics' concerns, which have been supported by research commissioner Philippe Busquin. Commission officials are in “internal debates about the extent to which academic research should be tied to the main directive”, she says.

Critics say that, unless the guidelines are worded appropriately, trials that the drug industry doesn't want to run could be endangered because academics could no longer afford to do them. Such trials include efficacy comparisons of drugs that are already in widespread use, and tests of procedures using surgery or medical devices.

Peter Boyle, director of the International Agency for Research on Cancer in Lyon, France, cites a recent 20-year cancer study as a potential victim of the rules. The Milan-based European Institute of Oncology's comparison of radical mastectomy against radical lumpectomy for breast cancer, he points out, “showed no difference in outcome between the procedures, so it had a huge impact for millions of women — but it's not likely that it could be done under the new rules because the administration costs would be too high.”

But the problem doesn't just relate to cost. Jane Armitage, a clinician at the University of Oxford's Clinical Trial Service Unit, UK, says that under the new rules, many trials that academics do now could not take place, because only drugs explicitly labelled for use in a trial could be used. “Many trials are based on doctors recommending patients to take — or avoid — aspirin, or other drugs that they do not provide themselves,” she says.

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