Register all human studies, says WHO
Pharmaceutical companies have been called upon to register all drug studies involving human testing, whether on patients or healthy volunteers.
The World Health Organization said last week that standard details of
all studies, including the earliest phase I toxicity studies, should
be recorded on publicly accessible registers. “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,” said
Timothy Evans, WHO assistant director-general.
The WHO is in the process of setting up an internet search portal that
will allow people to search all accessible trials registers that meet
the requirements of the WHO international clinical trials registry platform.
The platform defines 20 data sets that should be recorded.
But the International Federation of Pharmaceutical Manufacturers and
Associations has tempered the call with a warning that it could suppress
innovation. The association is concerned that companies might not carry
out any research and development in certain fields if they feel obliged
to provide information too early that is accessible to competitors.
“The pharmaceutical industry is convinced that it is vital to arrive
at a policy that encourages and promotes trial transparency without discouraging
the development of innovative new therapeutic approaches,” said
IFPMA director general Harvey E. Bale. |
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