UK drug companies to publish trial results online

Under the regulations, members of the ABPI, who include GlaxoSmithKline and AstraZeneca, will be encouraged to publish the results of trials during 2005 on their own websites in a standard format, with safety evaluations and no marketing.

Pharmaceutical companies will not be required to publish all data on all trials. However, a spokesperson for ABPI told E-Health Insider that the organisation believed that “pressure" from various sources, such as clinicians, patients and the media, would encourage companies to be fair and open, and that withheld data and information would be easily spotted.

“Each individual trial will have a different identifier," explained the spokesperson, saying that trials will be cross-referenced with each other for the ease of those doing research into one particular drug. Details of current trials underway may also be published, although there are no plans to make public results of trials from before 2005 in the same way.

Companies will publish reports on their websites, although many US trials are published in on the central clinicaltrials.gov website. A single website where all trials from 2005 are published is something “we are hoping for later on this year,” said the ABPI. “The World Health Organisation is talking about setting up a portal that would be one point of contact for all the databases."

Dr Richard Barker, director general of the ABPI, said: "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.

“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."

The agreement has been negotiated between the pharmaceutical companies and other national and international associations, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). According to the ABPI spokesperson, a global agreement was necessary as clinical trials often occur simultaneously in different countries and it was important that information about results in other countries should be available.

Health minister Lord Warner said of the agreement: “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."