As set out in the response by the government to the Lord O’Shaughnessy in his review of commercial trials.
Response section | Commitment | National lead | National implementation | HWE ICB |
---|---|---|---|---|
Costing and contracting | Enhanced National Contract Value Review (NCVR) approach introduced | NHSE | From Oct 2023 | Support organisations to review and manage impact |
60-day turnaround time for all approvals maintained | MHRA launched new notification scheme | MHRA | From Oct 2023 | Support organisations to review and manage impact |
UK performance indicators | Introduce new UK performance indicators with immediate effect | DHSC, DAs | By Nov 2023 | Support organisations to review and manage impact |
Return to pre-pandemic levels of performance and activity | No studies on the NIHR CRN portfolio that are more than 90 days past their planned opening date | NIHR | By end of 2023 | Support organisations to review and manage impact |
Establish a common approach to contacting patients about research | We will publish details of further actions based on the recommendations to support data enabled delivery of research April 2024 | DHSC, DAs | By end of 2024 | To be assessed |
Clinical research delivery embedded in the NHS | Updated GMC Good medical practice guidance comes into force in Jan 2024 | GMC | By Jan 2024 | Support organisations to review and manage impact |
Establish clinical trial delivery accelerator | Appoint clinical trial delivery accelerator host organisation | DHSC, DAs | By Feb 2024 | To be assessed |
Provide ‘real-time’ data on commercial clinical activity in the UK | Discovery work completed in full, providing essential foundations for effective implementation | NIHR | By March 2024 | To be assessed |
Streamlined, efficient and innovative clinical research | DHSC,the DAs, NHSE, HRA and NIHR will publish guidance and implement processes to improve site and sponsor engagement | DHSC, DAs | By March 2024 | Support organisations to review and manage impact |
Streamlined, efficient and innovative clinical research | NIHR CRN new approach to performance monitoring fully implemented | NIHR | By March 2024 | Support organisations to review and manage impact |
Clinical research delivery embedded in the NHS | NIHR CRN fully implements the new approach to performance monitoring initiated through Research Reset | NIHR | By March 2024 | Support organisations to review and manage impact |
Clinical research delivery embedded in the NHS | AMRC, DHSC and NIHR will publish by March 2024 a plan to work together to promote the benefits of clinical research to people working in the health and care system, patients and service users and the general public | AMRC, DHSC, NIHR, DAs | By March 2024 | Support organisations to review and manage impact |
People-centred research delivery | HRA, DHSC, NHSE and DAs will identify actions to be taken as a result of the HRA ‘hallmarks’ of people centred research report | HRA, DHSC, NHSE and DAs | By March 2024 | Support organisations to review and manage impact |
Provide ‘real-time’ data on commercial clinical activity in the UK | Publish implementation plan for delivery in FY 2025 to 2026, subject to business case | NIHR | By April 2024 | Support organisations to review and manage impact |
Establish a common approach to contacting patients about research | Final conclusions and recommendations will be published by the end of 2023. We will publish details of further actions based on the recommendations to support data enabled delivery of research April 2024 | HRA | By April 2024 | To be implemented when available |
Streamlined, efficient and innovative clinical research | In April 2024 NHS England will publish research finance guidance | NHSE | In April 2024 | To be implemented when available |
Streamlined, efficient and innovative clinical research | From April 2024, DHSC and HRA, on behalf of the devolved administrations, will expand the cohort of professionals across the UK providing pharmacy technical review and support uptake of these national reviews in local practice | DHSC, HRA | From April 2024 | To be implemented when available and if appropriate |
A sustainable and supported research delivery workforce | NHSE will publish a multi professional practice-based research capability framework for the healthcare professionals | NHSE | By spring 2024 | To be implemented when available |
Clinical research delivery embedded in the NHS | NIHR develops and implements an improved national process for faster industry site selection, details will be published by March 2024 and full implementation of changes in place by Oct 2024 | NIHR | By Oct 2024 | To be implemented when available |
A sustainable and supported research delivery workforce | DHSC and the devolved administrations will continue to provide funding for NHS support costs via the NIHR CRN | DHSC, DAs | From Oct 2024 | Ongoing |
Clinical research delivery embedded in the NHS | Contract for the new NIHR Research Delivery Network begins | NIHR | In 2024 | New contract from 1st Oct 2024 |
A sustainable and supported research delivery workforce | DHSC will develop and publish a workforce plan in support of The Future for UK Clinical Research Delivery | DHSC | During 2024 | To be implemented when available |
UK performance indicators | NHS England will develop a set of metrics which help ICBs and NHS providers understand their research performance | NHSE | End of FY 2024 to 2025 | To be implemented when available |
Research delivery enabled by data and digital tools | 1 million people have registered on Be Part of Research by March 2025 | NIHR, NHSE | By March 2025 | Promote #BePartofResearch |
People-centred research delivery | In FY 2024 to 2025, NHSE and DHSC will continue to support the ICS REN (Research Engagement Network) development programme | NHSE, DHSC | In FY 2024 to 2025 | Continue to support the Research Engagement Network activities |
Research delivery enabled by data and digital tools | By April 2025 the NHS Research SDE (Secure Data Environment) network will support over 500 users and 450 research projects through privacy-protecting accelerated access to multimodal data, including genomics, and over 45 million primary care records | NHSE | By April 2025 | Support the NHS Research SDE (Secure Data Environment) network |
Research delivery enabled by data and digital tools | Subject to successful discovery work by April 2025 local, regional and charity research volunteer registries will have the opportunity to link to Be Part of Research to form a national networked database of interested volunteers in research | NHSE, NIHR | By April 2025 | Support a network of interested volunteers in research via #BePartofResearch |
Research delivery enabled by data and digital tools | Continue to refine use cases and set out the case for implementation of data enabled approaches at scale in future | DHSC, DAs, NHSE, NIHR | Ongoing | Ongoing |