Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Life science competitiveness indicators published in July 2022, what steps his Department is taking to reduce the median time from clinical trial application to the first patient receiving a first dose for a subset of commercial trials.

The annual Life Sciences competitiveness indicators have highlighted that trial establishment times in the United Kingdom are slower than several of our competitors. In 2022, indicators showed that the median time was 247 days for a subset of commercial trials, with the UK ranked seventh out of 10. In March 2021, we published ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’ which highlighted improving the speed and efficiency of study set-up. This is being taken forward through the Recovery Resilience and Growth Programme. The Programme’s delivery partners are simplifying and streamlining processes to improve the median time from clinical application and first patient.

In 2021, a combined review by the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) reduced approval times for clinical trials to 61 days, compared to 90 days for those that did not go through combined review. ‘The Future of UK Clinical Research Delivery: 2022 to 2025 implementation plan’, published on 30 June 2022, includes actions designed to improve set-up times over the remainder of this Parliament, including:

- Implementing the UK-wide National Contract Value Review for commercial research to ensure costing does not delay study set-up in the National Health Service;

- Introduction of a single UK approval service to replace the HRA and Health Care Research Wales’ approval and equivalent processes in Northern Ireland and Scotland; and

- Further development of the Integrated Research Application System by the HRA and the MHRA to streamline health technology and medicines research.