The Department of Health has told us more detail behind UK Prime Minister David Cameron’s comments at G7, on the need for trials transparency in public health emergencies.
The new commitment is that whenever a UK Government body funds or co-funds research or work into diseases that are a threat to global health security, that work will be published in full. This includes diseases such as Ebola, Marburg, Lassa and Middle East Respiratory Syndrome.
The Department of Health said:
We already lead the world in making sure our clinical trial data is open to scrutiny, but we want to go further, particularly around diseases like Ebola which threaten global health security. It is vital that clear information on spread of disease and the impact of any measures to combat it is available to the WHO and those leading the response.
Data from UK-funded clinical trials of Ebola vaccines is already being made openly available. 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 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.
Ben Goldacre, author and co-founder of AllTrials said:
This is an extremely positive statement from David Cameron, and it’s great to see the UK showing leadership on such an important issue, on the global stage. In my experience the public are astonished to discover that the results of clinical trials are routinely and legally withheld from doctors, researchers, and patients. We have run a campaign on this at AllTrials.net for the past two years, and it is great to see the Prime Minister taking the issue seriously.
I have only two concerns.
Firstly, while public health emergencies are a great place to start, the UK surely needs to take a clear stand and make sure that all results, from all trials, on all uses of all treatments are made publicly available.
Secondly, I would question Dept Health’s claim that “we already lead the world in making sure our clinical trial data is open to scrutiny”. It would be good to see if this is true, but unfortunately we do not have adequate information to judge. The audits done by NIHR and MRC for the Select Committee inquiry into whether their funded trials are published have, themselves, never been published; and there has been no serious support from government funding bodies for those working on addressing the problem of withheld data in academia, despite the direct impact on patient care.
We need funders to engage seriously with this issue, and to publish routine ongoing audit of the clinical trials they fund at great public expense. We need a simple list of all trials where results have been made available, and all those where results are still being withheld.