The UK Government, through the Agency for the Regulation of Medicines and Medical Devices (MHRA) (UK Medicines Regulator), recently announced a consultation to change the UK's clinical trial regulations.

Following the UK's departure from the European Union, the UK government has sought to create an attractive regulatory environment for clinical trials, together with a program to improve the UK's position as a destination for the development of new healthcare products and innovation.

In July 2021, the government set out its broader life sciences ambitions in its Vision Life Sciences.

In depth

The current UK Clinical Trials Regulations are derived from the 2001 EU Directive. As a result of Brexit, the United Kingdom has not adopted the new EU Clinical Trials Regulations 2014, which entered into force on 31 January 2022.

The objectives of the consultation are broad and include gathering information on how to increase patient and public participation in clinical trials, improve the involvement and diversity of trial participants, and streamline clinical trial approval and processes. and improve drug labelling.

The consultation seeks views on proposed changes to the regulatory framework for testing that will apply in the United Kingdom and run until 14 March 2022, after which the government will publish a report and propose any future proposals. Such proposals will remain under the control of parliament until they become law. The new Medicines and Medical Devices Act 2021 provides the power to update UK clinical trials laws.

The discussion included the following important proposed changes:

Legal requirement for patient and public participation in research. Patient participation is currently expected as part of the approval of research ethics. The MHRA proposes to issue guidelines on how to comply with legal requirements.

Transparency in research

The proposals include the registration of clinical trials; publication of results; and sharing the results of the clinical trial with participants in an appropriate format within 12 months of the end of the trial or providing an explanation as to why this is not appropriate.

"Single entrance door" for approval processes. In line with the current approach piloted between the MHRA and the Health Research Authority, the proposals include a process for approving research ethics and clinical trials with timelines for legal assessment and response depending on the type of application.

Research on ethical information requirements. The MHRA proposes to remove the current legislative requirements for information provided in the application of the view on research ethics and to replace it with guidance that will allow flexibility in the future.

Greater flexibility is associated with more changes and timing in requests for additional information. This flexibility will allow better communication between sponsors and regulators during the evaluation.

Notification method for low intervention trials. For studies where the risk is comparable to standard medical care, the consultation suggests that a clinical trial may be approved without the need for regulatory review, but will require ethical approval. This proposal is in line with the Directive, but in practice this regime has not been used for a long time.

Greater inclusion of underserved populations. The consultation recommended the inclusion of regulatory requirements to promote diversity in clinical trials, for example in pregnant and / or lactating individuals. Simplify known cluster test authorization.

Changes to safety reports where these obligations do not contribute to the safety of participants, and elimination of duplicate reporting requirements.

Good clinical practice. The MHRA proposes changes to current legislation to include various elements of risk proportionality.
Electronic master test files. The MHRA proposes changes so that service providers are legally responsible for proper compliance with clinical practice.

New penalties and remedies. This includes allowing supervisors to take serious and persistent non-compliance when considering new studies, and allowing regulatory action against specific aspects of the evaluation rather than the overall evaluation.

Separation of labelling changes from the EU Clinical Trials Regulation.

A risk-based approach to the use of unexplored medicines (which will also be reviewed) for the labelling of certain products, including commercially licensed products and medicines in the place of care. This approach will allow such products to be reduced or eliminated in clinical trials.

Required for a specific reference and request to remove the EudraCT number for the United Kingdom.

Real world proof. The MHRA proposes to allow data collection after approval of timely access to the MHRA without the need for clinical trial approval. Ethical approval may still be required if necessary, as such studies are still considered clinical research.