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MPs warn of lack of progress cutting UK R&D red tape

17/09/2013

A group of politicians have warned of a lack of progress in streamlining clinical trial approval in the UK, while reiterating calls for publication of clinical trial summary reports to allow greater public scrutiny of results.

In a report into regulation and governance of clinical trials on Tuesday, the cross-party Science and Technology Committee said the Health Research Authority (HRA) was making slow progress in streamlining the UK's clinical trial approval process since its creation in 2011.

 

Reducing costs and bureaucracy involved with clinical trials was part of the government's strategy to boost life sciences research in the UK, which in turn was a key part of its master-plan to grow the country's economy.

 

Findings of the report were based on evidence from 62 organisations and oral evidence from 21 witnesses.

 

According to the report, a National Research Governance Service (NRGS) single portal for clinical trial approvals has not yet been created, which was recommended in a 2011 report by the Academy of Medical Sciences.

 

Witnesses said having to obtain separate approvals from each NHS organisation involved in a clinical trial is "by far the greatest impediment" to conducting them in the UK, above and beyond the already burdensome requirements laid down in the European clinical trials directive.

 

The HRA has conducted a feasibility study for clinical trial approvals, which reported in June 2013 and authors have made recommendations to the Department of Health.

 

A business case for implementation is being prepared, but the MPs called for the HRA to publish a timeline outlining next steps, ensuring the initiative should be given "the highest priority".

 

Meanwhile an academic health science research centre, King's Health Partners, and academics from the Royal Pharmaceutical Society and the National Pharmacy Clinical Trials Advisory Group, warned that most clinical researchers and R&D staff have little knowledge of its existence.

 

There was a lack of performance data so it was also impossible to judge whether the HRA has been effective, according to the report.

 

There was also a lack of evidence on how quickly NHS trusts were approving clinical trials because of a lack of monitoring, while a lack of public confidence in the pharma industry because of "past examples of poor behaviour" was also hampering recruitment of patients.

 

The MPs went on to back calls for publication of detailed clinical study reports (CSRs) once a regulatory decision about drugs has been reached.

 

Following calls from campaigners such as doctor and journalist Ben Goldacre, the MPs said they could "see no reason" why CSRs should not be put in the public domain, with identifiable patient data redacted.

 

The MPs argued that CSR publication would be "unduly burdensome" for non-commercial trials, however.

 

The European Medicines Agency is due to publish a policy on clinical trial transparency in November following a consultation, with a view to introducing new rules from January.

 

Source: www.apmhealtheurope.com


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