BioWorld International Correspondent

LONDON - Disquiet is growing in the UK that new EU rules on clinical trials will delay or stop publicly funded trials.

The rules are intended to protect patients and harmonize the conduct of clinical trials throughout Europe, but academics and research charities say the UK government's interpretation focuses only on large-scale commercial trials carried out to gain marketing approvals. As a result the proposed regulations are too onerous for researchers carrying out small-scale trials, they said.

The regulations are due to come into force May 1, 2004, and the government is consulting on its proposals for how the EU directive should be enshrined in UK law. It expects to complete this process some time in October.

Some of the loudest criticism has come from the medical charity Cancer Research UK, which claims that unless the proposals are changed virtually all trials of new treatment regimens carried out by researchers in hospitals and universities will be stopped, and recent improvements in cancer recovery rates will be jeopardized.

The charity funds trials of treatments that are of little commercial interest to drug companies, such as trials of new combinations of existing treatments and drugs. These trials often involve several institutions collaborating and pooling their results, but that would not be possible under the new proposals, which require that there must be a single sponsor running a trial centrally.

Last month, Cancer Research UK released figures showing that the number of cancer patients taking part in clinical trials has increased by 70 percent in the past two years. That follows the setting up of the National Cancer Research Network in 2001, to improve the speed and quality of clinical research in the UK. In the past five years the charity has funded 65 large Phase III cancer trials, and started 29 trials of new drugs.

But Peter Selby of Cancer Research UK warned that "all the good work will be threatened" if the proposed regulations come into force. He claims the one-size-fits-all approach proposed by the UK government fails to recognize the robust systems that public funding bodies already have in place to ensure high-quality research and patient safety.

Implementing the new proposals would lead to a fourfold increase in the cost of running clinical trials, without improving patient safety or trial quality, critics said. As a result there would be fewer trials, and important clinical questions would remain unanswered.

Richard Sullivan, head of clinical programs at Cancer Research UK, said the original aim of the EU directive - to simplify the process for allowing patients access to clinical trials - would not be achieved. It will be increasingly difficult to conduct cancer trials at a European level and that will impact orphan drug trials and pediatric cancer trials, he said.

The Medical Research Council has added its voice to the protest, saying there is a danger that the over-elaborate monitoring and reporting requirements will put funding bodies off sponsoring trials, and place unnecessary burdens on trialists. The results will be fewer and smaller trials.

The UK BioIndustry Association is concerned that the proposed legislation would undermine the UK's attraction as a location for carrying out clinical research. In particular, there would be additional costs of compliance, a requirement for any product entering clinical trials to be manufactured to full GMP standards, and it would take longer to get approvals for trials.