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Pharmaceutical companies
are looking askance at recommendations that they
publish plans for all clinical trials, including
early-stage proof-of-concept studies, on the Internet.
The proposal comes from the World Health Organization
(WHO).
The industry
selectively publishes details of later-stage clinical
trials (Phase IIb and beyond) on both individual
company Web sites and sites like the U.S.’s Clinicaltrials.gov.
That site saw a peak in activity in fall 2005 when
medical editors began demanding registration prior to
publication.
Since September 2005,
there has also been a comprehensive registry of trials
on the Web site of the International Federation of
Pharmaceutical Manufacturers & Associations (IFPMA).
That site describes 30,000 ongoing clinical trials and
summary results of more than 5,000 completed trials.
But WHO’s scheme goes
further. It is urging research institutions and
companies to register “all medical studies that test
treatments on human beings, including the earliest
studies, whether they involve patients or healthy
volunteers.”
Moreover, WHO is
insisting that pharma companies should be made to
reveal extensive data on every study, with researchers
having to publish 20 key details as soon as the study
begins.
WHO will allocate a
unique identifying number to every trial and then make
its database of identifiers available on its Web site,
providing a single point of access to all clinical
trials anywhere in the world.
Could registries help
patients and physicians? There is debate. Knowing
about drugs in the industry’s pipeline could help
desperate patients and might also make it easier for
journal editors to find every trial related to a
particular compound, and harder for research sponsors
to hide disappointing results.
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But the WHO proposal
has been criticized by both academia and industry as
overly cumbersome and threatening to innovation. “It
sounds like a recipe for a burgeoning bureaucracy,”
comments cancer researcher Karol Sikora at London’s
Imperial College. Sikora notes that WHO has poor links
to the R&D side of the pharmaceutical industry and
no drug development expertise.
Instead, Sikora would
like to see each country’s ethical committee keep a
mandatory database of trials and send a monthly return
of all approved studies to WHO for central
registration.
The industry’s
principal fear is of disclosing early-stage research
to competitors. “It’s Phase IIb and onwards that
are the medically significant trials,” says Richard
Tiner, of the Association of the British
Pharmaceutical Industry (ABPI). “They are the trials
that test efficacy, which is what patients have said
they want.”
Earlier trials usually
just show proof of concept, Tiner tells Pharma DD.
“Publishing those may simply confuse patients, raise
unrealistic expectations, and cloud medically
significant data,” he warns.
According to IFPMA
director general Harvey Bale, the industry is
concerned that companies might avoid exploratory
trials in certain fields if they have to reveal the
details of their work to competitors early in the
game. Doing so might cost them the chance to obtain
intellectual property protection. Bale warned that the
implications of WHO’s proposal needed to be studied
carefully in case it slowed or even blocked innovation
while giving no apparent benefit to doctors or
patients.
Still, both the ABPI
and IFPMA said they want to see more dialogue between
WHO, industry, regulators, and other stakeholders
before anything is set in stone. “We’re fully
committed to making available any and all information
that will advance patient safety, and we remain open
to further negotiation with WHO on their proposals,”
says Tiner.
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