Out-Law News 2 min. read

Clinical trials approvals process in UK criticised


Researchers wishing to conduct clinical trials in the UK face too many repeat approval processes, a committee of MPs has said.

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 said in its report into clinical trials.

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.

According to the Committee's report, many stakeholders within the life sciences sector have complained that the approvals procedures are overly bureaucratic. Evidence provided to the Committee identified one case where the principal investigator for a study involving 62 hospitals was subject to 62 separate criminal records bureau checks before being able to begin the trial.

"The system for gaining approvals to proceed with clinical trials in the UK is inefficient and costly to life sciences companies at a time when the Government is otherwise providing significant investment in the sector through initiatives such as the Biomedical Catalyst," said life sciences and intellectual property law specialist Camilla Balleny of Pinsent Masons, the law firm behind Out-Law.com.

 

"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. 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," she said.

Last year the Government set up the Health Research Authority (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 has 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 its report the Committee also set out recommendations in relation to the disclosure of data stemming from clinical trials.

It said all future clinical trials conducted in the UK, and all trials related to treatments used within the NHS should be registered, and the registration requirement should also apply retrospectively to trials for drugs currently used in the NHS. Summaries of the results from publicly-funded clinical trials should also be published, it said.

"We recommend that trial registration and publication of summary-level results be made contractual requirements for all publicly-funded trials ... and urge the Government to conduct a retrospective audit of all large public trial grants awarded since 2000 to ensure that they have been registered and published," it said.

The Committee also backed greater publication of fuller clinical study reports, but said that individual patient-level data should be subject to strict access controls, even if anonymised, in order to help protect individuals' privacy.

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