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BMJ. 2007 October 6; 335(7622): 691.
PMCID: PMC2001044

Doctors disagree about directive on European clinical trials

Contradictory details are emerging of the impact that the three year old European Union legislation on clinical trials is having on medical science.

According to research presented on 27 September at a conference in Barcelona organised by the European Cancer Organisation, the number of non-commercial clinical trials has fallen by a quarter. Markus Hartmann, from European Consulting and Contracting in Oncology, Trier, Germany, told participants that this figure was a “conservative estimate.”

But data from the European Medicines Evaluation Agency show that the percentage of non-commercial trials increased between 2005 and 2006. The agency and the European Commission launched consultations at a conference in London this week to analyse problems that the EU's clinical trials directive may have raised and to determine whether amendments to the legislation might be necessary.

Dr Hartmann based his research on six countries—the United Kingdom, Germany, France, Italy, Spain, and the Netherlands—all of which have submissions for at least 500 clinical trials a year. He examined the number conducted in the three years before and after May 2004—the date the legislation took effect.

The first category contained 13 000 trials, of which some 25% were non-commercial. While acknowledging that the sample in the second category is smaller—France and the Netherlands, for instance only applied the legislation from 2006—Dr Hartmann found that just 18.5% of trials were non-commercial.

“We are losing 25% of non-commercial clinical trials. It is clear that there is a trend and that non-commercial trials are more affected than commercial ones,” he told the BMJ.

The European Medicines Evaluation Agency's own database presents a different picture. It records 12 122 trials between May 2004 and August this year, of which 2388 (20%) were non-commercial.

The proportion that were non-commercial steadily increased from January 2005 to August 2007. In 2005 there were 3830 registered trials, of which 619 (16%) were non-commercial, while in 2006 there were 4291 trials, of which 866 (20%) were non-commerical. In the first eight months of 2007 there were 2936 trials, of which 694 (24%) were non-commercial.

“There are a number of issues on implementation. In the non-commercial sector, the need for change was greater, whereas industry was more familiar with the rules, especially their international aspects,” explained one Brussels official.

Michael Rees, the chairman of the BMA medical academic staff committee, agreed that the EU legislation is an important factor in the level of academic clinical trials but stressed that it is not the only one.

He pointed to “the general increase in bureaucracy that everyone seems to find a strain”; to the fall, certainly in the UK, in the number of academic medical staff over the past decade; and to the increased demands that hospital doctors face to meet delivery targets, leaving them less time for research.

Françoise Meunier, director general of the European Organisation for Research and Treatment of Cancer, cites other pressures.

“It is more and more complex to be a legal sponsor, especially for international clinical trials. You have to cope with different legislation and regulations since there is no harmonisation. At the same time, trials can take a year longer and costs are far higher,” she said.


Articles from The BMJ are provided here courtesy of BMJ Group