MHRA Launches UK Clinical Trial Regulation Consultation

The current UK clinical trial regulations are derived from the 2001 EU Directive. As a consequence of Brexit, the United Kingdom has not adopted the new EU Clinical Trial Regulation 2014, which came into effect on 31 January 2022.

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 labelling of medicinal products.

The consultation seeks views on the proposed changes to the trial regulatory framework applicable in the United Kingdom and will run until 14 March 2022, following which the Government will publish a report and any future proposals. Such proposals would remain subject to Parliamentary scrutiny before becoming law. The recent Medicines and Medical Devices Act 2021 provides the powers to update the United Kingdom’s legislation for clinical trials.

The consultation includes the following key proposed changes:

• Statutory requirement for patient and public involvement in research. Patient involvement is currently expected as part of research ethics approval. The MHRA proposes to issue guidance on how to meet the legislative requirements.
• Research transparency. The proposals include registration of clinical trials; publication of results; and the sharing of clinical trial findings with participants in a suitable format within 12 months of the end of the trial, or provision of an explanation of why doing so is not appropriate.
• “Single front door” for approval processes. In line with the current approach being piloted between the MHRA and the Health Research Authority, the proposals include a single research ethics and clinical trial approval process with timelines for statutory review and response depending on the type of application.
• “Sunset” provisions for applications. The MHRA proposes that clinical trial approval will lapse after a specified time limit if no participants have been recruited.
• Research ethics information requirements. The MHRA proposes to remove the current legislative requirements for information to be submitted as part of a research ethics opinion application, and to replace them with guidance that allows for flexibility in the future.
• Greater flexibility with respect to substantial amendments and timing of Requests for Further Information. This flexibility would allow more iterative communications between sponsors and regulators during a trial.
• Notification scheme for low-intervention trials. For trials where the risk is similar to that of standard medical care, the consultation proposes that the clinical trial could be approved without the need for a regulatory review but would require ethics approval. This proposal is in line with guidance, but in practice there has not been high uptake of this scheme.
• Greater inclusion of underserved populations. The consultation proposes the inclusion of legislative requirements to support diversity in clinical trials, for example pregnant and/or breast-feeding individuals.
• Simplification of informed consent in cluster trials.
• Changes in safety reporting where these obligations do not contribute to participant safety, and removal of duplicative reporting requirements.
• Good clinical practice. MHRA proposes changes to current legislation to incorporate more elements on risk proportionality.
• Electronic master trial files. MHRA proposes changes so that service providers are legally responsible for good clinical practice compliance.
• New sanctions and corrective measures. These include permitting regulators to take into account serious and on-going non-compliance when considering new studies, and enabling regulatory action to be taken against specific parts of a trial rather than the whole trial.
• Changes with respect to labelling that will diverge from the EU Clinical Trial Regulation.
• A risk-based approach with respect to the use of non-investigational medicinal products (which would be re-defined) for labelling of certain products, including those with a marketing authorisation and medicines at the point of care. This approach would allow such products to have reduced or no clinical trial labelling.
• Requirement for a UK-specific reference and removal of the requirement for EudraCT number.
• Real-world evidence. MHRA proposes to permit data collection after MHRA early access approval without the need for clinical trial approval. Ethics approvals may still be required as necessary, as such trials would still be regarded as clinical research.