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Last Updated: Friday, 19 May 2006, 09:27 GMT 10:27 UK
WHO urges drug trial registration
Northwick Park Hospital
Six men were left seriously ill after a trial at Northwick Park Hospital
The World Health Organization is calling for tighter registration of clinical drug trials so that negative findings cannot be kept secret.

The WHO is urging drugs firms and research bodies to register all medical studies on humans from the outset.

Currently researchers can opt to wait until they are well advanced in their work before reporting on results.

It follows disastrous drugs trials at London's Northwick Park Hospital which left six men seriously ill.

Many doctors are concerned about drug safety after a string of recent scares.

A recent survey in the US suggested that since medicines such as arthritis drug Vioxx were taken off the market because of higher heart attack risks, seven out of 10 doctors were more worried about prescribing.

Our aim is to make clinical research transparent and enhance public trust in science
Dr Ida Sim
WHO

The Geneva-based health body has drawn up a 20-point check list for the kind of information to be included in any registry of trials before they start.

It also plans to provide access to drug trial registries run globally by corporations, institutions and hospitals, through a new registry platform.

These would then have to meet certain standards set out by the WHO.

It is hoped the registry platform would provide standardised framework for what has to be reported to register a trial and ease identification.

Dr Timothy Evans, assistant director general of the WHO, said: "Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants."

Commercial confidentiality

He warned that new register would not prevent "adverse events" associated with drugs and vaccines but that it would provide the public with greater access to information.

Although registration would be voluntary, pressure from within the medical community is growing for greater openness.

A group of editors from 11 prestigious medical journals, the International Committee of Medical Journal Editors, argued that the results of clinical trials should not be published unless the trial had been recorded in a publicly-accessible registry.

But some firms said requirements such as these could jeopardise commercial and academic advantage.

Dr Ida Sim, coordinator of the registry initiative, said: "Our aim is to make clinical research transparent and enhance public trust in science, but we are in engaged in a fair and open process with all stakeholders.

"We look forward to continued dialogue about trial registration and results reporting as we move forward with the registry platform."


SEE ALSO:
Drugs trial rules are tightened
05 Apr 06 |  Health
Thousands may seek Vioxx damages
20 Aug 05 |  Business
Drug Trials: The Dark Side
24 Apr 06 |  This World


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