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Friday, July 1st, 2005
Links to major websites that list registrations of forthcoming
clinical trials are being made available
here on the website of
the Association of the British Pharmaceutical Industry (ABPI) from
today, when the global agreement on making such information publicly
available comes into effect.
With hyperlinks to seven different websites available, details of
more than 4,000 clinical trials, which are either completed, taking
place or planned, can be accessed. Of these, some 1,139 trials are
still ongoing and may be recruiting patients to take part.
"For some time, the UK-based industry has been firmly committed
to the principle of enabling public access to information about
clinical trials, and the establishment of these links on our website
is a further help to those who want information about such research,"
said Dr Richard Barker, Director General of the ABPI.
"This is merely the next step in the process - the international
industry is also in the process of establishing a portal to all
clinical trial websites worldwide - but it clearly demonstrates
our very real desire to make this information readily available
to those who want it."
Proposals to establish a worldwide register of clinical trials on
new prescription-only medicines were announced at the beginning
of the year. There are two elements to the proposals, which were
drawn up by the world's major 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. This came into effect in January
this year, with a maximum period of one year before publication.
- 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
on how to enrol. Forthcoming trials have to be listed from today
with those in various stages of progress by September 13.
The industry has committed 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.
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.
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. An internet portal will
be established before the end of the year by the International Federation
of Pharmaceutical Manufacturers' Associations (IFPMA), and the World
Health Organisation (WHO) is also committed to establishing a portal.
The ABPI listing of major websites is available by clicking
here. It includes hyperlinks to the US-based clinical trials
register, the ABPI's own UK-centred website, and the listings being
provided by five major, individual companies.
The initiative was drawn up following discussions between the European
Federation of Pharmaceutical Industries and Associations (EFPIA);
the IFPMA; the Japanese Pharmaceutical Manufacturers' Association
(JPMA); and the Pharmaceutical Research and Manufacturers of America
(PhRMA).
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