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Clinical trials: UK proposes risk-based regulation

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Some clinical trials will be able to be conducted in the UK without prior regulatory review under legislative reforms set out by regulators.

The proposals, developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) in collaboration with clinical research experts, are aimed at ending the existing “one size fits all” approach to clinical trials regulation in the UK and replacing it with a risk-based framework.

Life sciences expert Nicole Jadeja of Pinsent Masons said: “This consultation is a reflection of the dynamic approach the MHRA recognises can be taken in some circumstances to streamline the path of getting medicines to patients, without jeopardising their safety.”

Medicines and Healthcare Regulatory Authority

January 2022

Streamlining processes will support quicker timelines for overall trial approval compared with the current processes, and provide a competitive advantage, encouraging sponsors to run trials in the UK

Under current rules, clinical trials cannot go ahead in the UK until they have been scrutinised by a Research Ethics Committee (REC) and authorised by the MHRA. The MHRA said, though, that UK regulations could be more flexible and proportionate and better reflect changes in the way clinical trials are being designed.

Under the proposals, trial sponsors will be able to proceed with “low-intervention trials” without prior regulatory review. A new notification scheme would be enshrined in legislation and facilitate such trials instead. The requirement for an ethics review would, however, be retained.

“The proposed notification scheme is a way through which a sponsor can notify the MHRA about a clinical trial where the risk is similar to that of standard medical care, and the clinical trial can be approved without the need for a regulatory review,” the MHRA said.

The MHRA gave examples of what type of clinical trials would constitute a low-intervention trial under the proposed new regulatory framework. It includes trials of medicines that have been approved for human use elsewhere in the world where the trials seek to explore “the licensed range of indications, dosage and form”, or potentially even their ‘off-label’ use where this is “established national practice and supported by sufficient published evidence and/or guidelines”.

For clinical trials that do require prior regulatory approval, the MHRA set out additional plans to combine the regulatory and ethics review processes and cut the timeframe for joint review and decision making to 30 days from the date of acknowledgement of a valid application. Further maximum statutory timeframes are proposed in the context of cases where regulators request further information before deciding whether to approve trials.

“Streamlining processes will support quicker timelines for overall trial approval compared with the current processes, and provide a competitive advantage, encouraging sponsors to run trials in the UK,” the MHRA said.

In its consultation paper, the MHRA also set out plans to boost patient involvement in clinical trials. It intends to require trial sponsors to “work in partnership with people and communities (including patients and carers who have experience of living with the relevant condition) in the design, management, conduct and dissemination of a trial, or explain to the ethics committee as part of the application, why this is not appropriate”.

Plans to “embed research transparency in the regulation of clinical trials” were also outlined in the paper. The proposals, which the MHRA said would build on provisions outlined in the Health Research Authority’s ‘Make it Public’ strategy, include “a requirement to share clinical trial findings with participants in a suitable format within 12 months of the end of the trial, or explain why this is not appropriate”.

Other reforms mooted would allow trial sponsors to suggest their own labelling requirements for investigational medicinal products such as those with a marketing authorisation and medicines manufactured at the point of care. In some cases, no clinical trial specific labelling could be justified, the MHRA said.

Further proposals open to consultation include plans to reduce the burdens around consent in ‘cluster trials’, strip out some reporting requirements that “add burden to investigators but do not contribute to participant safety”, and build in new flexibilities to the sanctions framework.

The regulator further clarified that it intends to allow “‘non-interventional’ real world data collection”, without the need for clinical trial authorisation, in cases where it has already given approval to the use of unlicensed medicines, including through the ‘early access to medicines scheme’ (EAMS).

The MHRA published new guidance late last year that outlines how greater use of real world data for clinical trials could help expedite the availability of cost-effective treatments, and life sciences expert Helen Cline of Pinsent Masons said data is a topic life sciences businesses might want to address in response to the regulator’s consultation.

Cline said: “Looking ahead it will be important that changes to the clinical trial framework work to leverage the use of innovative tools and approaches to trial design and conduct, including the use of real-world data. Respondents to the consultation might also want to consider how the any new clinical trial framework can support the use of blockchain and artificial intelligence as tools to streamline data sharing and potentially optimise clinical research and use of new therapies.”

The MHRA’s proposals, which are open to consultation until 14 March 2022, come after the UK government pledged last year – in a life sciences vision developed with regulators and industry – to “radically improve” clinical trials regulation following Brexit so as to “create a more efficient and effective research environment”.

The MHRA said the responses received to its consultation will be used to inform final policy decisions and the drafting of new regulations.

June Raine, chief executive of the MHRA, said: “This is a once-in-a-generation opportunity to review and update the UK legislation for clinical trials in order to make the UK the go-to place to develop new and innovative healthcare products. Through the proposals outlined in this consultation we aim to reframe the legislation that underpins our regulation of clinical trials to deliver a more streamlined, transparent and flexible regulatory regime whilst always protecting patients and trial participants.”

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