[Top] [All Lists]

[e-drug] Drug Industry agrees to disclose all clinical trials information

E-DRUG: Drug Industry agrees to disclose all clinical trials information
[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]


Global Industry Position On Disclosure of Information About Clinical Trials
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 

<Prev in Thread] Current Thread [Next in Thread>
  • [e-drug] Drug Industry agrees to disclose all clinical trials information, E-Drug <=