The Medicines and Healthcare products Regulatory Agency (‘MHRA’), the UK’s medicines and medical devices regulator, has launched a consultation to review and update the UK legislation for clinical trials. This has been hailed by the MHRA’s Chief Executive, June Raine, as an opportunity to “deliver a more streamlined, transparent and flexible regulatory regime whilst always protecting patients and trial participants”.

As clinical trials may be designed and conducted by commercial, academic, or NHS organisations, the consultation seeks the views of manufacturers, healthcare professionals, researchers, developers, sponsors, investigators as well as clinical trial participants and the wider public in order to help shape improvements for the future.

The purpose of the consultation

The consultation, which is open until 14 March 2022, is available here.

It aims to reframe the UK legislation for clinical trials by responding to the needs of the sector by delivering a more streamlined and flexible regulatory regime while protecting the interests of patients and trial participants.

This aligns with the objectives of the Life Sciences Vision to make the UK the leading global centre for innovative research, design and delivery across all types and phases of trials. The Life Sciences Vision is the government and life science industry’s plan for the next decade to create a thriving sector and tackle some of the UK’s most significant healthcare challenges including cancer, dementia, and obesity.

Enabling the consultation

Following the UK’s departure from the European Union, the Medicines and Medical Devices Act 2021 (‘MMDA’) provides the powers and the mechanism whereby legislation in respect of medicines, devices and clinical trials can be updated. Part 2 of the MMDA sets out the powers for making amendments with the requirement for a consultation at section 45(1) of the MMDA.

The EU backdrop

The current UK legislation, The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, implemented the EU Clinical Trials Directive 2001/20/EC into national law. 

However, from 31 January 2022, the new Regulation (EU) 536/2014 (the ‘EU CTR’) applies in the EU. While there is a long and complex transition period, this new regulation significantly changes the process for applying for and conducting clinical trials in the EU, as well as updating the rules regarding the reporting of outcomes. The EU CTR harmonises the assessment and supervision processes and also sees the implementation of the long-awaited Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials, set up and maintained by the European Medicines Agency (‘EMA’) in collaboration with Member States and the European Commission. 

On 13 January 2022, the EMA also announced the launch of the Accelerating Clinical Trials in the EU initiative (‘ACT EU’), intended to transform how clinical trials are initiated, designed and conducted within the EU, encouraging the conduct of multi-state trials in particular. ACT EU will operate in conjunction with the new EU CTR and CTIS.

Against this backdrop and having left the European Union, the MHRA consultation takes the opportunity “to design a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as [a] world leading base for life sciences”.

Consultation objectives – safety and innovation

The consultation recognises that due to innovation in treatments and ever-advancing technology, the way in which clinical trials operate is evolving. There is a stated need to move away from a ‘one size fits all’ regulatory approach and instead to enable flexibility and proportionality in clinical trials legislation.

The regulation of clinical trials needs to provide for more innovative, high-quality and efficient clinical trials, streamlining clinical trial approvals, enabling innovation, enhancing transparency and bringing in greater risk proportionality. At the same time, the safety of all trial participants must be ensured with the promotion of patient and public involvement in clinical trials and improved diversity of participants.

Specific policy objectives include reducing unnecessary burden on those running trials; reducing the burden of disease on patients and society by facilitating the evaluation and development of new or better medicines; and building in international interoperability so that the UK remains a preferred site to conduct multi-national trials.

Key proposals in the consultation

Having set out the policy objectives, the consultation provides its proposals and the questions to which it seeks responses for the following key areas:

• Patient and public involvement - the MHRA set out plans to involve people with relevant lived experience in the design and development of research in order to improve its quality and relevance to participants and ensure that trials are as inclusive as possible.
• Research transparency - whereas clinical trials legislation is currently silent on transparency, although good practice guidance is in place, it is proposed to embed research transparency in the regulation of clinical trials.
• Clinical trial approval process - plans include enabling sponsors to make a combined MHRA / research ethics application submitted through a single UK ‘front door’, the Integrated Research Application System (‘IRAS’); and introducing a notification scheme for low-intervention trials 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 although an ethics review will still be required. 
• Research ethics reviews - it is proposed to promote and encourage the inclusion of under-served populations such as pregnant and/or breast-feeding women and increase diversity.
• Informed consent in cluster trials - simplifying the way that informed consent can be obtained in a way that is more proportionate to the low level of risk involved in cluster trials and encouraging wider uptake into these types of low intervention trials.
• Safety reporting - removing reporting requirements that add burden to investigators but do not contribute to participant safety.
• Good clinical practice (‘GCP’) - it is proposed to maintain a requirement for compliance with broad principles of GCP while updating the current principles to ensure flexibility and that they can be applied to a broad range of clinical trials.
• Sanctions and corrective measures – there are plans for more risk proportionate corrective measures.
• Manufacturing and assembly – it is proposed to introduce risk-proportionate requirements for the labelling of investigational medicinal products.
• Definitions and other terminologies - a number of definitions will be updated and the international harmonisation of definitions will be promoted.

Next steps

The way in which clinical trials operate is evolving and so is the legislation.  This consultation was both necessary and inevitable in the light of innovation in treatments and technologies as well as the changes taking place for clinical trials conducted in the EU. 

As with the MHRA consultation last year to update the UK’s medical device regulatory framework, the challenge will be to achieve a lasting balance between removing burdens and introducing improvements while always protecting those participating in trials.  

Responses to the MHRA will be used to inform the drafting of the amending legislation.