WHO seeks greater openness in clinical drug trials

GENEVA, May 19 (Reuters) The World Health Organisation (WHO) called today for all clinical drug trials to be registered from the outset and to help prevent companies from hiding negative findings.

A US survey on Thursday showed that seven in 10 doctors were more worried about the safety of drugs they prescribe after a series of recent high-profile scares, including the withdrawal of arthritis pill Vioxx in 2004.

The medicine was taken off the market by its manufacturer Merck&Co after a clinical trial showed it doubled the risk of heart attack and stroke after 18 months' use.

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

The Geneva-based health body plans to set up a registry ''platform'' -- or portal -- through which access could be gained to several hundred trials' registries run globally by corporations, institutions and hospitals.

At the same time, the agency set out a 20-point check list for the sort of information to be included in any registry.

Asked about the Vioxx case, Evans said the WHO plan could have made a difference had it been operating because side-effects associated with Vioxx had not been fully reported and information had been difficult to access.

''This will not prevent adverse events associated with drugs and vaccines. (But) it will provide the public with a greater access ...

which will perhaps decrease the likelihood of those adverse events happening,'' he told journalists.

As things stand, researchers can opt to wait until they are well advanced in their work before filing anything.

While the individual registers would continue to exist, the WHO's platform would provide a single entry point to find out about research concluded or in progress.

The new measures could also help boost efficiency in research by cutting down the risks of duplication.

''Above and beyond building trust through transparency, more comprehensive knowledge on what is being done will allow for efficiencies to be gained by making sure that results are much more easily accessible,'' Evans said.

Reuters SK GC0533