Delays, bureaucracy and complexity are seriously undermining research and slowing medical advances, according to an Academy of Medical Sciences report, without improving patient safety. The report recommends creating an independent research agency to be the sole regulator.
“We have found unequivocal evidence that health research in this country is being jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome”, said Michael Rawlins, chair of the working group that prepared the report.
Furthermore, increased regulatory and governance burden has failed to improve patient safety, according to Rawlins, and consequently the report recommends streamlining the process.
The Labour government commissioned the report in March 2010 and, following the UK general election, the incoming coalition reiterated support for the project. Andrew Lansley, secretary of state for health, said the government will look at how to implement the report’s recommendations.
Other representatives of the UK government, pharma industry and charities, including Allison Jeynes-Ellis, medical and innovation director at the Association of the British Pharmaceutical Industry (ABPI), also welcomed the report.
“[ABPI] very much supports key recommendations that focus on streamlining the processes around clinical trials and address the cultural issues that still exists within some parts of the NHS, which represent a significant hurdle in conducting clinical research”, said Jeynes-Ellis.
Health Research Agency (HRA) creation
The HRA would incorporate the functions of the National Research Ethics Services and other approval bodies to provide researchers with a “one-stop shop” for ethical approval. A National Research Governance Service (NRGS) housed within HRA would perform checks for NHS trusts.
“It is vital that the HRA is established as soon as possible. To achieve its goals it will have to be a genuine single regulator and not a mere façade hiding the continuation of many separate existing bodies”, said Rawlins.
To be a success the HRA must: be created as soon as possible; build and maintain the confidence of stakeholders; take a UK-wide approach; streamline processes; and have strong leadership that represents the lay public and research community.
The HRA should work alongside the UK Medicines and Healthcare products Regulatory Agency (MHRA), which was considered as a single regulator, to assess whether clinical trial authorisation is needed.
Outsourcing-Pharma will take a more in-depth look at the report’s comments on the MHRA and UK regulation of clinical trials in a follow-up article.