GlaxoSmithKline To Open Access to Clinical Trial Data for Research - iHealthBeat

abernard102@gmail.com 2012-10-12

Summary:

"On Thursday, pharmaceutical company GlaxoSmithKline announced plans to make much of its drug data from clinical trials available to other researchers beginning in 2013, Reuters reports. The announcement comes three months after GSK reached a $3 billion settlement with the federal government and pleaded guilty to charges that it provided misleading information on certain drugs, including the antidepressant Paxil and the diabetes drug Avandia (Hirschler, Reuters, 10/11). Opening Access to Data Under the new policy, GSK will establish an independent panel of experts to review information requests submitted by researchers, which will be evaluated on scientific merit. The company then will make that data available to scientists on a secure website. The policy will apply to global clinical trials dating back to 2007, as well as all clinical trials for drugs that have completed the approval process or have been abandoned starting in 2013. GSK also plans to release information for 200 of its experimental drug compounds that have shown signs of fighting tuberculosis. Joshua Sharfstein -- Maryland's health secretary and the former principal deputy commissioner at FDA -- said, 'Making data available, particularly on the products that didn't succeed, could avoid others having to learn the same lessons..."

Link:

http://www.ihealthbeat.org/articles/2012/10/11/glaxosmithkline-to-open-access-to-clinical-trial-data-for-research.aspx

From feeds:

Open Access Tracking Project (OATP) ยป abernard102@gmail.com

Tags:

oa.medicine oa.new oa.data oa.policies oa.comment oa.litigation oa.pharma oa.biomedicine oa.glaxosmithkline oa.announcements

Date tagged:

10/12/2012, 16:09

Date published:

10/12/2012, 12:09