WHO seeks greater openness in clinical drug trials

GENEVA (Reuters) – The World Health Organization (WHO)
called on Friday for all clinical drug trials to be registered
from the outset and to help prevent companies from hiding
negative findings.

A U.S. 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.