Efforts being made to streamline clinical trials approvals process, says HRA

In response to a report into clinical trials published last month by the House of Commons' Science and Technology Committee, the HRA said that it has already assessed what "additional resources" it would need to create a new system of assessment and approval for clinical trials within the NHS.

The HRA said that the new system proposed would combine the separate processes that currently exist for obtaining authorisation to proceed with research and development and sign-off for the studies from an ethics committee.

"We very much welcome the support for the HRA's work to streamline research approvals in the NHS, and have submitted plans to our Board for further consideration," the HRA said in its response paper. "This includes the assessment of additional resources required to deliver this work to streamline both R&D and REC (Research Ethics Committee) approval into a single HRA assessment and approval."

"One key advantage of a single approval process will be greater simplicity and opportunity to measure metrics from a common starting point for approval – HRA validation. The plans will be published once agreed," it added.

Before conducting clinical trials, researchers must obtain regulatory approval. In the UK this process can require researchers to engage with a number of different bodies.

Authorisation to proceed with trials in the UK is required from the Medicines and Healthcare products Regulations Agency (MHRA), whilst an ethics committee must also approve proposed studies. Researchers also require approvals from each different NHS body that is involved.

Life sciences expert Louise Fullwood of Pinsent Masons, the law firm behind Out-Law.com, said that it combing R&D and REC approval would be welcome if the move could be achieved "in a practically efficient way" and so long as duplication could be avoided.

In its clinical trials report last month, the Science and Technology Committee said that the Government had "failed to eliminate" what it dubbed "the biggest barrier to initiating a trial in the UK – the requirement for numerous, and potentially duplicate, governance approvals from participating NHS organisations".

"More can and should be done to make the UK a more attractive location for clinical trials," the Committee added at the time.

Last year the Government set up the HRA which, among other duties, has responsibility for operating the National Research Ethics Service and operating an electronic system through which researchers can apply for some regulatory approvals.

The Science and Technology Committee said that whilst most of the feedback about the HRA's performance to date had been positive, it called on the body to better communicate how it can help facilitate clinical trials research, and said that it should also ensure that "the necessary performance indicators" are in place to allow an assessment to be formed on how well it is doing its job.

In response the HRA acknowledged that "the changing NHS and regulatory landscape may have meant that some were not yet aware of the HRA" in the past and said that it is in the process of settling on a new communications strategy.

It also said that it had set "metrics" for measuring its performance against all its current objectives and that it is "working with others to ensure those metrics are as widely supported as possible and capture the full research journey for health research in the UK".

Life sciences and intellectual property law expert Camilla Balleny of Pinsent Masons, last month said that the "inefficient and costly" system for gaining approvals for clinical trials in the UK was at odds with the support the Government was otherwise providing life sciences companies with through initiatives such as the Biomedical Catalyst. 

"Much of the bureaucracy stems from the EU's Clinical Trials Directive, but it is clear too that the way the UK has implemented that Directive has also caused concern," Balleny said. "The European Commission has signalled its intent to reform the Directive and it is hoped a new Clinical Trials Regulation will be in place by 2016. However, it should be possible to encourage more clinical trials to be conducted here in the UK prior to then by removing the duplicate and unnecessary bureaucratic burdens in the approvals process that researchers currently encounter."

The Government is also expected to issue a separate response to the Science and Technology Committee's report.