Are Clinical Trial Data Shared Sufficiently Today?

On bmj.com yesterday [Tuesday 9 July 2013] two authors debated the issue of publicly sharing clinical trial data. This will also be the subject of this week's reader poll on bmj.com. Ben Goldacre, research fellow at the London School of Hygiene and Tropical Medicine, says we need all the evidence to make informed decisions about medicines. The lack of progress on transparency has been startling, he writes. Current estimates suggest that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be published. There is legislation mandating greater transparency - such as the law requiring trial results to be posted on the website clinicaltrials.gov - but the published evidence now shows that this legislation has been largely ignored. He also calls for trials from the past to be fully disclosed, since more than 80% of the medicines prescribed this year came onto the market more than a decade ago. Claims that it's enough for regulators to see all the information on trials expose patients to "real and unnecessary risks," he adds, because problems with evidence are also identified by academics and doctors working outside of regulatory bodies. He says that Clinical Study Reports - long documents held by regulators and companies on the full methods and results of trials - should be shared publicly, with information about individual patients redacted where necessary. He explains that 1.6 milli...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs