Proposals to establish a worldwide register of clinical trials on new prescription-only medicines are being fully endorsed by the UK-based pharmaceutical industry, the Association of the British Pharmaceutical Industry (ABPI) announced today.
Under the proposals, drawn up by the world's major pharmaceutical 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.
Also, 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 about how to enrol. Both requirements will be adopted by the worldwide pharmaceutical industry during 2005.
The announcement has been welcomed by Health Minister Lord Warner, who said: "It is very welcome that the main representative bodies of the international pharmaceutical industry have confirmed their agreement with the principle of registration and disclosure of clinical trials.
"It is for the whole industry to take forward practical measures giving effect to this agreement speedily, especially given the context of the global initiative on clinical trials discussed at the Mexico health research summit in November."
Dr Richard Barker, Director General of the ABPI, said: "The UK-based industry took a world lead in providing the public with information about clinical trials work more than 18 months ago when the ABPI established its own website for companies to register information about trials. We are therefore very pleased that the industry globally is moving to build on this by providing information about trials wherever they may have been conducted, and the initiative has the full endorsement of the industry in the UK.
"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 publishing not just the results of trials that have taken place - whether positive or negative - but also those that are just starting, the industry has made a major step towards achieving greater transparency.
"It is now up to the other sponsors of clinical trials to commit themselves to follow suit."
The industry is committing 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.
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.
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.
The initiative has been drawn up following discussions between the European Federation of Pharmaceutical Industries and Associations (EFPIA); the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA); the Japanese Pharmaceutical Manufacturers' Association (JPMA); and the Pharmaceutical Research and Manufacturers of America (PhRMA).
For further information, please contact: ABPI Press Office 020 7747 1410