GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.
In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.
The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.
Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.
According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.
The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.
Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.
GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.
In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.
Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.