A new independent review panel will decide to grant access to GSK’s clinical trial data based on scientific merit.
GSK announced its commitment to make trial data available to researchers earlier this week, citing a desire to further scientific understanding and knowledge as the primary motivation.
Company spokesman David Daley told in-Pharmatechnologist.com that: “We will be making accessible data from globally conducted clinical trials (Ph I – IV) since 2007, together with all clinical trials initiated after January 2013 under the new commitment.
“All proposals requesting access to these data will be reviewed for scientific merit by the independent review panel that we are establishing. Requests for data collected prior to 2007 will continue to be assessed by GSK on a case by case basis, as they are now. We’ll continue to look at these requests – with the aim to share as much as we can – depending on practicalities, to support genuine scientifically valid requests.”
He added that the data will be for both authorised drugs and those that did not make it through the clinical trial process, explaining that the information will be provided through a secure, password protected website along with the required analytical software.
Earlier this year GSK was forced to pay the US Government $3bn in a case that involved failure to publish trials showing that the drug Paxil was ineffective in children .
This and a number of other high profile cases prompted regulators on both sides of the Atlantic to reassess the drug industry’s publication of trial data.
In August , the EMA called for CROs and sponsors to share trial data, specifically they request that companies make such information publicly available.
More recently in the US, the HHS has announced its intention to hand oversight of Clinicaltrials.gov – the website where drugmakers are required to post clinical data – to the Food and Drug Administration (FDA ).