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Clinical Trial Regulation: A streamlined reform of the UK Clinical Trials Regulatory Framework - new measures published

The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation held between 17 January to 14 March 2022. 

The objective of the reforms is to produce a simpler, more streamlined framework following the UK’s departure from the European Union, demonstrating the UK’s ability to house global ‘multi-site’ clinical trials and to make the UK one of the best countries in the world to conduct clinical research for patients and researchers. This is set against the backdrop of the UK government announcing on 20 February 2023 an independent review into the UK commercial clinical trials landscape following a 44% fall in recruitment of patients to commercial clinical trials between 2017 and 2021.

The current legislation that governs clinical trials in the UK is the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is based off the EU Clinical Trials Directive and has not been amended to align with the subsequently introduced EU Clinical Trials Regulation. According to the MHRA, the UK’s departure from the European Union has opened up an opportunity to reform the legislation in a way that encourages innovative development, whilst maintaining public safety.

To ease the application process for clinical trials in the UK, the new measures will provide for a combined regulatory and ethics approval process with globally competitive approval timelines. The MHRA is to enforce a 30-day maximum limit for the completion of an application review, supplemented by a maximum 10-calendar day window for a decision to be granted once the regulator has received all information.

The new legislative requirements will introduce a legal mandate to register the trial in a World Health Organisation (WHO) - compliant public register, ensuring that the public are aware of trials being conducted, unless the Research Ethics Committee agrees to a deferral. Also with respect to transparency and trial participant involvement, there will be a legislative requirement to publish a summary of the trial results within 12 months of the trial end date and to share findings with the participants in a prompt manner. 

Under the new legislation, the regulatory requirements of a specific clinical trial will match the risk profile by introducing a notification scheme for low intervention trials. For example where the risk is low i.e. similar to standard medical care, the notification scheme will allow for the clinical trial to be approved without regulatory review. This is intended to ensure that greater regulatory resources can be diverted to higher risk trials of more innovative drugs.

Specific guidance on the diversity of trial participants is set to be published which is intended to lead to more inclusive trials thereby yielding results that are more representative of patient populations. 

Fundamentally, these measures are intended to ensure a dynamic shift in the UK’s clinical trial field, highlighting the importance of international interoperability, regulatory flexibility and transparency. 

The next step will be for the draft legislation to implement these measures to be prepared and published before it is adopted as secondary legislation.   

This blog post was co-authored by Yasmin Dilhe, Trainee Solicitor.