To dispel the secrecy that shrouds drug-industry trials, GlaxoSmithKline announced last week that it will make the trove of detailed raw data underlying its clinical trials available to researchers. Declan Butler reports for Nature News.
This is a huge step forward because data from clinical trials are rarely shared fully with other scientists — meaning doctors make important decisions about patients and care based on incomplete information.
Greater openness about clinical-trial data should help to speed up drug development, provide independent assessments of drug safety and efficacy and increase trust in industry science. It could also put an end to the scandals that, over the past few years, have seen almost every major drug company fined hundreds of millions of dollars for putting profits before patient safety and welfare, often through selective data reporting.
(In July, GSK reached a $3-billion settlement with U.S. authorities for fraud, including publishing “false and misleading” accounts of trials, and for hiding data on safety concerns.) Transparency is the only way forward for the industry.
GSK now intends to make available anonymized patient-level data for all trials it has carried out since 2007 for both approved and abandoned drugs (only post-2007 data is in formats suitable for sharing, the company says).
This is the first of such commitments for big players in the industry. Starting next year, the European Medicines Agency (EMA) intends to open up access to all new clinical-trial data sets received from industry for product registration.
[Via Nature News]