1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in the United Kingdom in relation to Decentralized Clinical Trials (“DCTs”) with medicinal investigational products.

Following the United Kingdom’s departure from the European Union (Brexit), the UK Government is seeking to create an attractive regulatory environment for clinical trials alongside a program that is intended to enhance the United Kingdom’s status as a go-to destination for the development of new healthcare products and innovation. The Government set out its wider life sciences ambitions in July 2021 in its Life Sciences Vision. 

The overarching vision is to make the UK the leading global center for innovative research design and delivery, across all types and phases of trials, supporting virtual and decentralized trial delivery and further enhancing expert early advice for researchers via the Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) to support efficient trial design, approval, and start-up. There are benefits of early engagement with the MHRA and it would encourage sponsors to contact the MHRA as early as possible for regulatory advice on decentralized clinical trials. This is an age of change, adopting new technologies, decentralized trials, novel trial designs, and encouraging diversity in clinical trial designs.  

The current UK clinical trial regulations are derived from the 2001 EU Directive. As a consequence of Brexit, the UK has not adopted the new EU Clinical Trial Regulation 2014, which came into effect on 31 January 2022. After Brexit, the UK passed the Medicines and Medical Devices Act 2021 which provides the powers to update the United Kingdom’s legislation for clinical trials. On 17 January 2022, MHRA announced an 8-week consultation to change the UK clinical trial regulations. This consultation specifically relates to clinical trials and the medicinal products used in clinical trials (Investigational Medicinal Products, ‘IMPs’). The responses to this consultation are currently being reviewed and will feed into the decisions that are made to finalize the proposals and consideration of the drafting of the secondary legislation in the UK. The Government will publish a report and any future proposals which would remain subject to Parliamentary scrutiny before becoming law. 

The consultation’s objectives are wide and include gathering information on how to increase patient and public involvement in clinical trials, improve engagement and diversity of trial participants, streamline clinical trial approvals and reporting processes, share research findings with the health community more transparently, and improve labeling of medicinal products. These proposals are to update the current UK legislation that governs clinical trials, The Medicines for Human Use (Clinical Trials) Regulations 2004” (SI 2004/1031), as amended, which transposes the EU Clinical Trials Directive 2001/20 EC into UK law. 

The HRA published, in December 2023, a position statement on “Decentralized trial methods”.