Drug firms to publish all trial data
placing patient safety at risk, pharmaceutical companies worldwide
have agreed to reveal the results of clinical trial drug data.
Major industry players including Glaxosmithkline, Pfizer and Novartis have agreed to publicise their trial results on a voluntary database, which will be available online from 1 July this year, while some trials will be included on the register by mid-September.
The pharmaceutical industry has recently taken a battering over the controversy surrounding drug trials after the withdrawal of the painkiller Vioxx and alleged suppression of data concerning the anti-depressant Seroxat. The government are consulting with the industry on making it a criminal offence to mislead the regulators about any application to sell a drug.
Dr Richard Barker, director general of the ABPI endorsed the move saying: "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."
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 with mixed success.
UK Health Minister Lord Warner added: "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."
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 also ensure that all such sites are linked, since several companies have already set up their own arrangements.
The results are expected to be published within one year after the medicine is approved or, for post-approval trials, within one year of them being completed.
