Brussels, 10 Jan 2005
A worldwide voluntary register of clinical trials for new prescription-only medicines has been endorsed by the four major international pharmaceutical associations, including the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The four associations have agreed that the results of clinical trials, both ongoing and completed, should be made freely available online. Pharmaceutical companies will not be required to publish all data on all trials but will be encouraged to publish the results, regardless of outcome, along with safety and benefits evaluations.
'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 making public not just the results of trials that have taken place - whether positive or negative - but also information on those that are just starting, the industry has made a major step towards achieving greater transparency,' said Brian Ager, EFPIA Director General.
The 'Joint position on the disclosure of clinical trial information via clinical trial registries and databases' aims to make information about results globally available. Clinical trials often occur simultaneously in different countries.
In 2004, pharmaceutical companies also found themselves accused of highlighting positive trials while playing down negative data on areas such as the paediatric use of antidepressants. The scheme will therefore ensure 'complete transparency'.
The industry is committing to making available information on all clinical trials, other than exploratory trials, although those results will also be published if they provide significant medical importance.
As EFPIA explains, the results will be published in a standard, non-promotional summary that will include a description of the 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. Furthermore, 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.
'It is now up to other sponsors of clinical trials to commit themselves to follow suit,' concluded Dr Richard Barker, Director General of the Association of the British Pharmaceutical Industry (ABPI). To read the 'Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Database' in full, please visit: http:///www.efpia.org/4_pos/sci_regu/Clin icaltrials2005.pdf