update
Data from all UK-funded vaccine trials to be published says PM
Cameron told attendees at the G7 Summit in Germany that from now on any UK-funded research, data or operation will be made 'openly available” and that the UK "will look to develop an international agreement – via the G7 – that would see the publication of results of all clinical trials of vaccines for relevant diseases.
“Ebola showed us that when data on disease outbreaks is not shared quickly, the disease can get out of control” Cameron said.
Quite what this international agreement will involve is unclear as Professor Sally Davis, the UK’s Chief Medical Officer, and colleagues at the World Health Organisation (WHO) are still developing a “new, more advanced system to share data” according to Cameron.
The comments are in keeping with a call for data from trials of Ebola vaccines and candidate treatments to be shared that was issued by the WHO at the height of the outbreak last year.
They also fit with regulations adopted by European institutions in April 2014 that are designed to force drugmakers to submit results from all clinical trials for publication on an open access database.
ChAd3 unaffected
The publication decision will not impact GSK, whose candidate Ebola vaccine ChAd3 is currently being examined in combination with Emergent Biosolutions’ MVA EBOZ product in a Phase I trial at the Jenner Institute in the UK.
A GSK spokesman told us the firm “will continue to share data and information about our vaccine from the ongoing trials in a timely way to help inform ways to tackle the current outbreak and to prevent future outbreaks of Ebola.”
He explained GSK has been making trial data available since 2004 and in February 2013 the firm announced its support for the AllTrials campaign, which calls for the registration of clinical trials and the disclosure of trial results and clinical study reports (CSRs).
A Department of Health (DoH) spokesperson told us "The UK supported phase 1 clinical trials of GlaxoSmithKline’s vaccine candidate through the Joint Global Health Trials partnership, in collaboration with the Medical Research Council and the Wellcome Trust.
"The GSK vaccine is in phase II and III clinical trials in West Africa. GSK is a signatory to the Alltrials pledge – which binds signatories to register and publish trials results, whether the findings are positive, negative or indifferent."
The spokesperson added that: "The Prime Minister has written to all relevant Government Departments to make clear that he expects this practice to continue, unless there are significant national security implications."
