Red tape 'threatens research'

Drug trials are already heavily regulated

Beefed-up regulation of clinical trials could hold back vital research, warn experts.

The director of the Medical Research Council's clinical trials unit says that the extra form-filling and inspections demanded by a planned EU directive could actually cut the number of research projects undertaken in the UK.

The new measures are mostly intended to improve patient safety and confidentiality.

These regulations certainly mean a lot more work, and the implications are worrying for us

Professor Janet Darbyshire

While Professor Janet Darbyshire says that she agrees with this principle, she said it could mean so much extra work that specialists and hospitals are less prepared to take on new projects.

This could mean it takes much longer for new medicines to reach patients.

Professor Darbyshire said: "These regulations certainly mean a lot more work, and the implications are worrying for us.

"It could take longer to set trials up, and longer to actually do them."

Another UK research specialist says over-complex research, is also stifling progress towards new medicines.

Call for simplicity

Professor Richard Gray, director of the Clinical Trials Unit at the University of Birmingham, is calling for simpler trial procedures.

He told the European Society of Medical Oncologists conference in Hamburg that many trials involve too many demands on patients, such as calling them in for extra investigations or follow-up visits to hospital.

In addition, the burden on medical staff through form filling and data collection can also prove too great, he said.

"Because of the huge amount of work involved in planning, organising and getting funding for a big trial, it is tempting to use it as an opportunity to get as much information as possible about the patients and their treatment.

"But, ironically, this desire to get as much detail as possible makes the study less informative because it puts off doctors and patients whose involvement is so crucial.

"The additional workload drives up costs and delays the availability of results."

He said that the lack of patients who could be attracted to take part in major trials meant that many did not have enough to produce robust results.

Professor Sir Richard Peto, of the Imperial Cancer Research Fund's Oxford unit, agreed: "The quicker a clinical trial is completed, the sooner potential new treatments for cancer patients will be made available, giving more patients a greater chance of living longer."

He added: "Of course there should never be any compromise on patient safety or scientific value, but less complex trials make sense.

"They mean less workload for the doctors conducting the trials and less money spent on the trials."

A spokesman for the Association of the British Pharmaceutical Industry, which represents companies developing new medicines, said that a lot would depend on how the new directive is implemented in the UK.

He said: "We have concerns over the length of time to get a new drug through this process."