Click to go to homepage
You are not currently logged in


 Basket Items: 0    Total: 0.00 

NEWS STORY

UK clinical trials regulator rejects unrestricted publication of trial data

29/10/2013

The UK's clinical trials regulator has rejected blanket publication of anonymised patient-level data from studies because of risks to patient confidentiality, saying that it should decide whether researchers are allowed access to the information on a case-by-case basis.

The Health Research Authority (HRA) made the comments in a response to the House of Commons Science and Technology Committee's report into clinical trials, adding that it should act as an independent "gatekeeper" to a database containing the data.

 

According to an emailed document from the HRA, this gatekeeper would be responsible for evaluating research proposals and this sensitive data is handled responsibly and "in a way that makes a useful contribution to scientific knowledge."

 

The HRA said: "We are not in favour of placing individual patient-level data in the public domain in an unrestricted manner, as we consider that the risk to patient confidentiality is too great and, for many past and current trials, this level of disclosure would go beyond the confines of previously obtained patient consent."

 

The HRA went on to propose that it should develop and run a central repository for such data, while also acting as gatekeeper.

 

In the response, the HRA added that the so-called "Ingelfinger Rule" banning scientists from publishing the same original research in two different outlets, should be removed to allow faster access to scientific data.

 

The HRA added that pharma companies working with National Health Service (NHS) organisations in clinical trials could gain greater credibility with a sceptical public, potentially boosting recruitment of patients to clinical trials.

 

In its response, the HRA said that its work with market research firm Ipsos MORI showed the public had a "high level of trust in research undertaken by the NHS, but had less trust in research done by the pharmaceutical industry."

 

"More recent work, which is yet to be published, shows that knowing that pharmaceutical industry research that takes place in the NHS increases public trust," authors added.

 

The HRA said that it will shortly be publishing plans to streamline NHS research by removing bureaucracy, although it did not provide a specific timetable.

 

Source: www.apmhealtheurope.com


» Send this news item to a friend or colleague

« Back to list

 

Quick Links

The Royal Society of Medicine
Be part of a GP''s day with OnMedica

 

Wilmington plc e-shot  |  Developed by forfront.net