Trials disclosure uncertainty

The pharmaceutical industry may soon have no choice but to make available for public consumption much more, if not all, of its data from clinical trials of new medicines.

The plan, which is taking effect globally, will see drug industry associations in the US, Europe and Japan come together to develop a new, industry-wide, policy to publish on the internet detailed information on both ongoing and completed trials.

The move, while currently voluntary, comes in the midst of a furore regarding the issue of integrity when it comes to reporting fair and balanced trial results and will see significant pressure put on pharma firms to cooperate.

Indeed, UK health minister Lord Warner, who earlier this year accused the industry of ìfoot-draggingî on the issue, warned of ìalternative measuresî if the industry did not act. Some have speculated that the new policy pre-empts future legislation that will serve the same end.

Several other voluntary initiatives, such as online clinical trial registers, have been set up and run in recent months, of which some are fully independent and run by pharmaceutical companies and associations.

GlaxoSmithKline and Eli Lilly & Co both employ such registers. Lilly announced that it would disclose the results of all company-sponsored clinical trials of its marketed products via a publicly available registry, available for viewing from Q4 2004. The firm also noted that the project was 'consistent with the company's policy of open disclosure', though it was unavailable for comment on whether it would be required to participate in the new scheme as well.

The Association for the British Pharmaceutical Industry (ABPI) also set up a trial registry, though with the political debate on the issue intensifying - and just seven of the 80 ABPI members having used the facility - the new policy will look to go much further than previous efforts.

ìWe are trying to establish some comprehensiveness and transparency of information,î affirmed Richard Barker, director-general of the ABPI.

The plan has been given additional momentum by a group of leading medical journals which have threatened not to publish any findings from any pharmaceutical clinical trial that was not registered under the new scheme from the outset.

However, the new policy does not yet require the disclosure of 'exploratory trials' on healthy subjects, or address any concerns regarding the way in which the trials were conducted.