Recommendation 28

HM Government Acknowledged

The multi-year Vision for the Future of UK Clinical Research Delivery was published on 23 March 2021. The vision describes how we will build on the lessons learnt during the pandemic, and sets out our ambition to create a patient-centred, pro-innovation and digitally enabled clinical research environment for all disease areas, including cancer research. Implementing the vision will unleash the true potential of our clinical research environment to improve health, capitalise on our renowned research expertise, and make the UK one of the best places in the world to design and deliver research. (a) Making it easier for researchers to access vital patient data The NHS England Data for Research and Development (R&D) Programme will invest up to £200m to develop an England-wide ecosystem of NHS owned and managed Trusted Research Environments (TREs) to allow researchers access to secure, high-quality, linked datasets. TREs are an analytic layer that provide approved researchers with safe, secure and rapid access to multimodal data and analytical tools enabling R&D without the data ever leaving the NHS. It will also convene stakeholders and make investments to support faster, effective, innovative and more diverse clinical trials by developing a data- driven clinical trials service (‘Find, Recruit, Follow-up’) and, through interoperability and federation of genomics datasets, enable access to a range of linkage-enriched genomics datasets (b) Making it easier for researchers to access staff needed for their studies, by providing more protected time for research in NHS contracts: The Vision sets out our commitment to create a research positive culture across the NHS and to a develop a sustainable and supported research workforce, offering rewarding opportunities and exciting careers for all healthcare and research staff of all professional backgrounds. Progress during the Phase 1 implementation period has included the development of new professional roles, expansion of our flexible workforce and delivery models, and increased capacity for research in primary and community care research through the NIHR Clinical Research Network. (c) Making it easier for researchers to get studies open for recruitment swiftly, by streamlining ethics and other approval processes: • The Vision sets out our commitment to improve the speed and efficiency of study set-up. By simplifying and streamlining the route to study set up, incorporating greater transparency and consistency in research approvals and by expediting the processes for costing and contracting, we can reduce delays and speed up all aspects of study set-up. The combined review from the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Research Ethics Services, in collaboration with the HRA, facilitates speedier set up for clinical research trials by requiring applicants to only make a single application for both Clinical Trial Authorisation (CTA) and Research Ethics Committee (REC) approval. • HRA now offers 50% faster REC review for non-COVID clinical trials following a pilot in 2021. Available for global trials and first-in-human studies, developing medicines in key areas of patient need such as cancer, the service uses an expert fast-track committee to provide a consistent and efficient approval process. • The Innovative Licensing and Access Pathway (ILAP), a joint initiative between MHRA, National Institute for Health and Care Excellence, Scottish Medicines Consortium (SMC) and All Wales Therapeutics and Toxicology Centre, formally launched in 2021. The ILAP is an entirely new approach to the licensing and regulation of the most innovative, transformative treatments. This new pathway has established partnerships to robustly and safely support the development of the most innovative and needed new medicines. • The Experimental Cancer Medicine Centre (ECMC) Network, with support from MHRA and HRA, is delivering a pilot to set up phase 1 oncology trials within 80 days of application for research approvals. The new ways of working are being co-created by all of the relevant stakeholders, including regulators, sponsors, R&D teams and investigators to create a scalable system that has benefits cancer research and other Phase 1 studies.