ABPI makes a clinical click
Links to major websites that list registrations of forthcoming clinical trials are now available on the website of the Association of the British Pharmaceutical Industry (ABPI) (www.abpi.org.uk).
Links to major websites that list registrations of forthcoming clinical trials are now available on the website of the Association of the British Pharmaceutical Industry (ABPI) (www.abpi.org.uk).
The move took place on 1 July, which was when the global agreement on making such information publicly available came into effect. Hyperlinks to seven different websites and details of more than 4,000 clinical trials - which are either completed, taking place or planned - are available. Of these, 1,139 trials are still ongoing and may be recruiting patients.
Proposals to establish a worldwide register of clinical trials on new prescription-only medicines were announced at the beginning of the year. Two elements of the proposals, which were drawn up by the world's major industry trade associations with the involvement of the ABPI, call for the results of all industry-sponsored clinical trials on a medicine that has been approved for marketing to 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); and for details of all clinical trials determining a medicine's therapeutic benefit to be publicly registered at initiation so that patients and clinicians will have information on how to enrol.
'For some time, the UK-based industry has been firmly committed to the principle of enabling public access to information about clinical trials,' said Dr Richard Barker, director general, ABPI. 'This clearly demonstrates our very real desire to make this information readily available. The international industry [and the WHO] is in the process of establishing a portal to all clinical trial websites worldwide.'
Forthcoming trials have to be listed with those in various stages of progress by September 13. 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. If the results are also published in a peer-reviewed medical journal, the database will include a link to the article.
The results should normally be published within one year of approved or, for post-approval trials, within one year of completion.