Consultation on Proposals for the Future of UK Clinical Trial Legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) is playing a fundamental role in ensuring that the United Kingdom remains one of the best places in the world to research and develop safe and innovative medicines. In August 2021, as part of a wider piece of work around clinical trials in the UK, MHRA launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products, or ‘CTIMPs’ (1,2)

Since Jan. 1, 2022, the combined review service (previously known as ‘combined ways of working’) offers a single application submission route and a co-ordinated review for CTIMPs, resulting in a combined regulatory and ethics decision on a clinical trial. Applications for combined review are prepared and submitted in a new part of the Integrated Research Application System (IRAS).

Building on the CTIMPs, and as part of a vision to improve the speed and efficiency of clinical research approvals,on Jan. 17, 2022 MHRA launched a public consultation on a set of proposals to improve and strengthen the UK clinical trials legislation (the Medicines for Human Use [Clinical Trials] Regulations 2004 as amended) (3).

“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,” said June Raine, chief executive of MHRA, in a press release (3).

MHRA outlined a set of proposals to reframe the UK legislation for clinical trials, deliver a more streamlined and flexible regulatory regime, all whilst protecting the interests of patients and trial participants.These proposals have been developed by MHRA and the Health Research Authority (HRA), in collaboration with an expert working group of stakeholders from across the clinical research sector, including patient representation.

Highlights of selected legislative changes

Updates to clinical trial application processes and approvals. To simplify and streamline applications, MHRA proposes a range of changes including:

• amendments in the request for information (RFI) process
• introduction of a notification scheme for low-intervention trials
• updated requirements for research ethics committees

• certain UK definitions.

The target here being that the ensuing regulations reflect current practice, reduce burden on those conducting trials, and remove legislative blockers to innovation.

It would also set a 30-day maximum timeline, from receipt of a valid application, for joint MHRA and ethics review to provide an initial decision (i.e., approval of application or a request for further information).

Public involvement and research transparency. MHRA is seeking views on legislating the requirement for public involvement to ensure information on clinical trials is publicly available and that patients are involved in trial set up from the very early stages. Proposals further outline that a summary of the trial findings must be published within 12 months of its completion.

Updates to safety reporting requirements. In a move likely to be welcomed by industry and researchers alike MHRA is aiming to remove some of the more burdensome safety reporting requirements without impacting participant safety. The suggested plan is to introduce more flexibility around the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) by removing the requirement for individual SUSARs to be reported to all investigators while they will still be informed via Investigator Brochure (IB) updates.

Manufacturing and assembly. MHRA are proposing changes to introduce proportionate requirements for the labeling of products manufactured or imported for clinical trials. It will be interesting to see how this plays out with regards to [Manufacturer/Importer Licence] MIA(IMP) sites and Qualified Person release of IMPs, for example.

Good clinical practice (GCP) and corrective measures. The consultation seeks views on updating a number of specific changes in current GCP principles with a key one being providing flexibilities to enable more proportionate regulation of lower-risk trials. There is no apparent wish to deviate from the International Council for Harmonisation GCP. In these low intervention trials, the revised legislation is aiming to simplify the means of seeking agreement. This should make such trials more feasible and will widen the reach and participation.

To avoid duplication of requirements and reduce potential confusion, most specifically around multi-country trials, MHRA is aiming to update trial terminologies.

Overall, MHRA is clearly trying to position the UK as a leading player in the global clinical trial sphere. The legislative changes are targeting an improved speed and efficiency of approvals, enabling innovation all whilst enhancing clinical trial transparency. It is promising to see the potential for the UK to regain some status as a leading global center for innovative research design and delivery.

This consultation, open from Jan. 17, 2022 until March 14, 2022, will hopefully result in an efficient and effective clinical trials environment, which allows faster access to new, innovative treatments for patients. Broughton is committed to accelerating life-enhancing products to market and supports MHRA’s drive to deliver a more flexible and streamlined regulatory regime.

To help shape the future legislation for clinical trials in the UK, you can respond to MHRA questions using this link.

References

1. MHRA, Clinical Trials for Medicines: Apply for Authorization in the UK, Guidance, gov.uk [Published Dec. 18, 2014, Last updated Jan. 7, 2022].
3. HRA, Combined Review, Information on CTIMPs, hra.nhs.uk [Last updated Feb. 17, 2022].
2. MHRA, “New Proposals for the Future of UK Clinical Trial Legislation,” gov.uk, Press Release, Jan. 17, 2022.

About the author

Lloyd Smart is head of Regulatory Affairs at Broughton