A new era for UK clinical research and innovation?

In March 2023, the UK Government published its response to a public consultation on proposals to reform the legislation governing the regulation of clinical trials of human medicines in the UK, namely the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended.

The consultation was led by the Medicines and Healthcare products Regulatory Agency (MHRA) and The Health Research Authority (HRA), in collaboration with an Expert Working Group of stakeholders from the clinical research industry. It received over 2000 responses, with significantly high engagement from patients and the public (88%), and organisations involved in the design and conduct of clinical trials.

The government's primary aims are to:

  • Create a more streamlined and flexible regulatory regime while ensuring that patient safety remains at the heart of all clinical trials; and
  • Make the UK a more attractive venue for clinical trials and research, paving the way for the development of new medicines and promoting the UK’s reputation as a world leading base for life sciences.

The government is currently drafting legislation to implement the proposed changes set out above. An update is expected in Autumn 2023.

Looking ahead, life sciences businesses will be examining the new legislative proposals to identify opportunities for the rapid development and launch of innovative medicines and treatments that would not have been possible – or would have taken significantly longer – under the existing regime.

The future regime forms part of a wider commitment by the government to expedite clinical trials, as announced in its response to Lord O’Shaughnessy’s independent review of UK commercial clinical trials published in May 2023. A pledge of £121 million of funding has been made to facilitate innovation in this area. It is also cited as a factor that will help deliver the MHRA’s strategic priority of enabling “healthcare access to safe and effective medical products” as set out in its Corporate Plan for 2023-2026 published on 4 July 2023.

We will report on future developments.

The government's response to key legislative proposals

Key proposals Government response
Patient and public involvement: Inclusion of patients and the public in the design, management, conduct and dissemination of research to be made mandatory. The government will introduce detailed guidance on patient and public involvement, but will not make it a legal requirement as it could disincentivise trial sponsors to run trials in the UK.

Improvement of research transparency, to include:

  • Registration of trials in a World Health Organization (WHO) public registry and publication of a summary of results; and
  • Sharing clinical trial findings with participants within a year of trial conclusion, or their reasons for not doing so.
As increased transparency would support scientific rigour and evidence-based decision making, the government agrees to introduce a legislative requirement for a summary of results to be published within 12 months of the end of the trial, unless a deferral has been agreed.

Streamlining the regulatory approval process:

  • Sponsors to submit a combined application to the MHRA and Research Ethics Committee (REC) through the Integrated Research Application System (IRAS), instead of separate applications;
  • The MHRA and REC to have 30 days to approve the application or request further information (RFI); and
  • The MHRA and REC to have 10 days to respond, once the RFI responses have been received.
The government intends to carry this proposal forward into legislation, with clear guidance to be issued thereon.
Low Intervention Trials: A notification scheme to be introduced for
Low Intervention Trials i.e. where the risk is similar to that of standard medical care. The sponsor would notify the MHRA about such trials and obtain approval without requiring a full regulatory assessment.
The government intends to adopt this into legislation, though such trials would still require a review by a REC. Details on eligibility for the scheme to be set out in guidance.
Relaxation of Informed Consent requirements in cluster trials, i.e. trials conducted on existing approved medicines, where randomization to a certain treatment is pre-determined by location, and which present little or no risk to participants. The government will (i) adopt flexibility on consent provisions in trials regarded as lower risk; and (ii) develop accompanying guidance to ensure that the need for adequate informed consent is not compromised.

Reduced administrative burden of SUSAR reporting, by:

  • Removing the requirement for sponsors to directly report Suspected Unexpected Serious Adverse Reactions (SUSARs) to investigators and RECs;
  • Allowing for annual safety reports to be submitted only to the MHRA;
  • Allowing reporting of SUSARs to the MHRA in an aggregate manner, where justified and approved; and
  • Extending the timeline for written notification to the MHRA regarding urgent safety measures for the protection of trial participant safety.
The government plans to adopt these proposals into legislation, notwithstanding the mixed responses received.
Compliance with principles of Good Clinical Practice of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP): Encouragement of UK trial sponsors to comply with the ICH GCP (and to only use GCP compliant vendors) to ensure the integrity of trial data. The government will legislate to specifically align UK requirements with the ICH GCP.

Risk-proportionate sanctions and corrective measures:

  • Risk proportionate corrective measures be taken (e.g. refusing study approval) where a sponsor or investigator has a history of serious non-compliance; and
  • Where an error is made only on one part of a trial, there is an option to stop only that part.
The government will not proceed with this proposal, particularly as such measures would risk a reduction of trials being conducted in the UK. Following authorization, powers already exist for regulators to require a trial to be amended, suspended or terminated.
Definitions and inclusive terminology: Introducing risk-proportionate definitions (e.g. Patients who join a trial will be called “participants,” not “subjects.”) Given the strong support for updating and modernising the definitions in current UK legislation, the government will take forward this proposal.

Alignment with international clinical trial regimes

The government’s proposals to update the existing UK legislative framework follows the introduction of the EU’s new Clinical Trials Regulation (EU) 536/2014 (CTR) which made significant changes to the original regime provided for by the EU Clinical Trials Directive (2001/20/EC). The CTR took effect on 31 January 2022. Owing to Brexit, the CTR did not apply in Great Britain although most of it continues to apply in Northern Ireland, subject to the provisions of the Windsor Framework.

Similar to the CTR, the proposed reform of the UK regime will provide for a more streamlined and efficient approvals processes, enhanced clinical trial safety, increased transparency and better facilitation of the evaluation and development of new medicines.

The proposed alignment with the Good Clinical Practice Principles of the ICH - which is widely accepted as the international standard to assure trial participant safety and integrity of trial data - demonstrates that the UK intends to align, insofar as possible, with the clinical trial regimes in the EU and other jurisdictions globally to make the UK an attractive venue for international and multi-site clinical trials.

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