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Thursday, January 6th, 2005
Proposals to establish a worldwide register of clinical trials
on new prescription-only medicines are being fully endorsed by the
UK-based pharmaceutical industry, the Association of the British
Pharmaceutical Industry (ABPI) announced today.
Under the proposals, drawn up by the world's major pharmaceutical
industry trade associations with the involvement of the ABPI and
agreed by major companies, results of all industry-sponsored clinical
trials on a medicine that has been approved for marketing, and which
evaluate its safety and benefit, will be publicly disclosed via
free, publicly accessible databases, regardless of outcome.
Also, details of all clinical trials being performed to determine
a medicine's therapeutic benefit will be publicly registered at
initiation so that patients and clinicians will have information
about how to enrol. Both requirements will be adopted by the worldwide
pharmaceutical industry during 2005.
The announcement has been welcomed by Health Minister Lord Warner,
who said: "It is very welcome that the main representative
bodies of the international pharmaceutical industry have confirmed
their agreement with the principle of registration and disclosure
of clinical trials.
"It is for the whole industry to take forward practical measures
giving effect to this agreement speedily, especially given the context
of the global initiative on clinical trials discussed at the Mexico
health research summit in November."
Dr Richard Barker, Director General of the ABPI, said: "The
UK-based industry took a world lead in providing the public with
information about clinical trials work more than 18 months ago when
the ABPI established its own website for companies to register information
about trials. We are therefore very pleased that the industry globally
is moving to build on this by providing information about trials
wherever they may have been conducted, and the initiative has the
full endorsement of the industry in the UK.
"The industry recognises that there are important public health
benefits associated with making clinical trial information more
widely available to healthcare practitioners, patients and others.
By publishing not just the results of trials that have taken place
- whether positive or negative - but also those that are just starting,
the industry has made a major step towards achieving greater transparency.
"It is now up to the other sponsors of clinical trials to commit
themselves to follow suit."
The industry is committing itself to making available information
on all clinical trials, other than exploratory trials - and even
those results will be published if they have significant medical
importance.
The results will be published in a standard, non-promotional summary
that will include a description of trial design and methodology,
results of primary and secondary outcome measures described in the
protocol, and safety results. However, if the results are also published
in a peer-reviewed medical journal, the database will alternatively
include a link to the relevant article and, in some cases, the summary
as well.
Rather than placing all information on a single website, the industry
will ensure that all such sites are linked, since several companies
have already set up their own arrangements.
The results should normally be published within one year after the
medicine is approved or, for post-approval trials, within one year
of them being completed.
The initiative has been drawn up following discussions between the
European Federation of Pharmaceutical Industries and Associations
(EFPIA); the International Federation of Pharmaceutical Manufacturers'
Associations (IFPMA); the Japanese Pharmaceutical Manufacturers'
Association (JPMA); and the Pharmaceutical Research and Manufacturers
of America (PhRMA).
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