Tuesday, September 17, 2013

UK government 'must push for clinical trial transparency' - MP committee calls for publication of results from clinical trials using NHS treatments

All clinical trials conducted on treatments made available under the NHS in the UK should be registered and their results published, according to MPs.

The Commons' Science and Technology Committee said the government has not been doing enough on trial transparency; a situation which is "undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk", according to committee chair Andrew Miller.

The report warns that unfavourable results from clinical trials are often going unpublished and many trials are not registered before they are carried out, with researchers in both industry and academia found to be at fault.

The MPs paint a picture of systemic failures in trials oversight, from the government down. For example, it says the Health Research Authority (HRA), which oversees the research ethics committees (RECs) that monitor trials in the UK, found earlier this year that fewer than 50 per cent of RECs were checking whether researchers planned to publish their results before giving approval.

The report comes as the pharma industry is fighting a rearguard action to try to limit the data from clinical trials that is made publicly available amid increasing pressure for full reporting of clinical trials, including all results and trial methods.

The European Medicines Agency (EMA) wants full disclosure of trials on all the drugs it approves, while the AllTrials campaign, whose signatories include organisations such as NICE, IQWIG and GlaxoSmithKline, is calling for a complete register of trials, including retrospectively, as well as summary results alongside methods, and access to anonymised patient-level data for use by researchers only.

The committee's report also does not favour uncontrolled release of potentially sensitive patient data, although Miller notes that "raw trial data is currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients".

The Association of the British Pharmaceutical Industry (ABPI) recently published guidelines for pharma companies on trial data disclosure, while the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) also published a joint code of practice on trial transparency in July that is due to come into effect on January 1, 2014.

Critics have argued that these self-regulatory approaches do not go far enough, and, while the committee applauds the efforts in its report, it asks companies to go even further, for example by publishing "a common set of clinical trial transparency metrics each year in their annual reports".

The MP group is not in support of the AllTrials bid for retrospective registration of all studies, however, saying that while this is "desirable", it would "almost certainly be unachievable given the likely time and resources that this would require". It favours a selective, 'index' approach to retrospective trial publication on an ad hoc basis.

The government should consider ways to incentivise pharma companies to boost data transparency, and suggests that the proposed change towards value-based pricing (VBP) and the current renegotiation of the Pharmaceutical Price Regulation Scheme (PPRS) could be a means to achieve this, said the MPs.
They also take a poke at the bureaucracy in securing approval for trials that they say is stifling the UK's clinical research sector by making it hard to get trials running and recruiting patients.

"We are confident that the government is aware of these problems and the need to resolve them, but its promises have yet to be matched by effective action," concludes the report.


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