GlaxoSmithKline to begin publishing trial data
Drugmaker GlaxoSmithKline (GSK) has announced its intentions to start publishing clinical study reports (CSRs) and clinical trial results in an effort for increased transparency, making it the first major drug company to do so.
GSK will begin publishing CSRs for all drugs once they have been approved or discontinued from development and the results have been published, the company said in a statement. Researchers and regulators would have first review of the data, with identifying patient data removed to ensure confidentiality.
The move comes in the wake of a $3 billion settlement GSK paid out in July 2012 after admitting to charges of manipulating trial data, hiding unflattering scientific studies, and enticing physicians to prescribe the antidepressant Paxil. The company admitted to covering up studies and other evidence that showed Paxil caused harmful side effects in children, including suicidal ideation.
GSK announced it would develop a system where researchers will be able request access to detailed anonymous patient-level data that sit behind the results of clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge. The company stated that the initiative is part of a commitment to greater clinical trial transparency.
In addition, GSK will have teams working on publishing all CSRs and trial data dating back to the company’s formation in 2000, when Glaxo Wellcome merged with SmithKline Beecham. “Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years,” the statement said. “Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.”
The company already publishes some clinical trial data online at http://www.gskclinicalstudyregister.com/, with summary information on about 5,000 clinical trials. GSK will also look to publish evaluations of its medicines in peer-reviewed journals.
“We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research,” says Patrick Vallance, President, Pharmaceuticals R&D, GlaxoSmithKline. “All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organizations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”