E-DRUG: Drug Industry agrees to disclose all clinical trials information
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[Drug Industry associations have finally agreed to disclose all Clinical Trials
information. Selectively publishing the positive ones was no longer an option.
This is good news for pharmaceutical science! See below a press release from
IPFPMA. Copied as fair use. WB]
http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=2205
Global Industry Position On Disclosure of Information About Clinical Trials
IFPMA
Geneva, 1/6/2005 - Today the research-based pharmaceutical industry is
announcing principles of disclosure of clinical trial information through
clinical trial registries and databases. The International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA) has jointly developed
these principles together with three other industry associations: the European
Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese
Pharmaceutical Manufactures Association (JPMA) and the Pharmaceutical Research
and Manufacturers of America (PhRMA).
The Joint Position on the Disclosure of Clinical Trial Information via Clinical
Trial Registries and Databases demonstrates the innovative pharmaceutical
industrys commitment to increasing the transparency of clinical trials
sponsored by their member companies. The industry recognises that there are
important public health benefits, including increased confidence, associated
with making clinical trial information more widely available to healthcare
practitioners, patients and others, said Dr. Harvey E. Bale, Director General
of IFPMA. Beginning mid 2005, the industry will make the results public of
trials that have taken place whether positive or negative but also
information on those that are just being initiated.
Under the proposals, drawn up by the worlds major pharmaceutical industry
trade associations and agreed by major companies, summary results of
industry-sponsored clinical trials completed from today onwards on a medicine
that has been approved for marketing, will be publicly disclosed via free,
publicly accessible databases, regardless of outcome. Also, details of ongoing
clinical trials being performed to determine a medicines 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 industry is committing itself to making available information on all
clinical trials of importance to patients health. These include all such
trials except exploratory trials and even those results will be published if
they have significant medical importance, Dr Bale added.
Trial 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.
If the results are published in a peer-reviewed medical journal, the database
will include a link to the relevant article
The results will be published within one year after the medicine is approved
or, for post-approval trials, within one year of them being completed.
About the IFPMA
The International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA) is a non-profit, non-governmental organization (NGO) representing
national industry associations and companies from both developed and developing
countries. Member companies of the IFPMA are research-based pharmaceutical,
biotech and vaccine companies. In the current research and development
pipeline, our industry is working on more than 700 new medicines and vaccines
for infectious diseases.
For More Information Please Contact
Lena Jansson
Communications, IFPMA
P.O. Box 758
1211 Geneva 13, Switzerland
Email: l.jansson@ifpma.org
Tel: +41 (22) 338 32 00
Fax: +41 (22) 338 32 99
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