Pharmaceutical manufacturer GlaxoSmithKline is making waves for the second time in the last four months, announcing that in response to a new clinical trials data transparency initiative, it will commit to make all clinical study reports (CSRs) publicly available through its proprietary clinical trials register.
GSK made a similar announcement in October 2012, when it said that it would soon publish clinical trials data using a secure database available to select researchers, part of a compromise it said was aimed at placating open data advocates and those (including the company itself) who expressed concerns that public data could be linked with individual trials participants, violating confidentiality procedures.
"As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," added Sir Andrew Witty, CEO of GSK. At the time, some industry watchers questioned if the move-unprecedented in both its size and scope-could be a harbinger of things to come in the industry.
The company had been infamously linked in the past to some major clinical data transparency concerns, including those over data linked to the diabetes drug Avandia (rosiglitazone) and the antidepressant Paxil (paroxetine), both of which were found to be less safe than initially assumed when suppressed data was made available to regulators.
To date, no other major companies in the pharmaceutical or medical device industry have followed GSK's lead.
But increased pressure could change that dynamic. As reported by Regulatory Focus in January 2013, a new collaboration has sprung up in the hopes of pressuring companies and legislators to open up their clinical trials data to the public. That initiative, known as the AllTrials initiative, is being backed by a number of prominent voices, including academic and author Ben Goldacre, the British Medical Journal (BMJ) and the Cochrane Library.
"All involved parties need to work to ensure that all results of all clinical trials-past and future-on all treatments in current use are available to doctors and patients, so that they can make informed decisions about treatments," the group wrote in a research piece posted on its website. The group's petition has already garnered more than 23,000 signatures as of the time of this article's publication.
All GSK Trials Ever Conducted to be Made Public
GSK acknowledged that initiative in its 5 February 2013 statement on its website, saying its own actions "further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign."
The company further noted that since its October 2012 announcement, it has made 5,000 of its CSRs available online, which it said are accessed by more than 10,000 visitors each month.
CSRs contain information about the trial's design, methods and results-what GSK called the "basis of submissions to the US Food and Drug Administration, the European Medicines Agency (EMA) and other regulatory agencies."
Going forward, GSK said all CSRs will be published once a medicine has been approved or discontinued from development and the results have been published. "This is to allow for the data to be first reviewed by regulators and the scientific community," GSK explained. "Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained."
Notably, the company also said it would seek to publish all CSRs for trials dating back to the company's founding-an undertaking the company said may be accompanied by "practical challenges," including the difficulty of removing identifying patient data from a massive volume of trials.
That move was surprising to some industry watchers, including Paul Ivsin of the industry blog Placebo Control, who called it a "major surprise."
"That wasn't going to be
required by any law anytime soon," Ivsin said in an email to Regulatory Focus. "[The move] seems to be a genuine over-and-above
effort by GSK for which they'll deserve a ton of credit when they start doing
Ivsin added that he felt the new announcement was less substantial in importance than the company's October 2012 announcement, but said it nevertheless adds to a sense that full CSR publications seem "inevitable."
"The European Medicines Agency (EMA) is already moving in this direction, [and] FDA will follow suit
either through pressure or (most likely) through new legislation," he said. "GSK may have
accelerated that process by 2 or 3 years. That's not earth-shattering, but it's
good and important, and entirely refreshing to see a company in industry
showing some actual leadership."