Research Recovery and Reset
The UK clinical research delivery system is facing unprecedented challenges to support the delivery of research, following the COVID-19 pandemic. The ongoing impact of the pandemic on elective backlog, workforce pressures, as well as the need to complete existing COVID-19 research, has led to delays in the completion of studies. This has resulted in a substantial reduction in the number of studies able to recruit effectively and close on time.
The capacity of the NHS to support research delivery remains under continued pressure from workload and workforce issues, as well as the need to reduce the elective backlog. Limited capacity and resource means that some studies have struggled in the current environment and have little chance of meeting their research endpoints and objectives. For others, the reduced resource and capacity means that study delivery within acceptable timescales is threatened. It is essential that the research system focuses on the studies that can be delivered with the capacity and resource available, whilst recognising there are some studies (e.g. in rare diseases) for which recruitment is expected to be less regular.
The Department of Health and Social Care and colleagues in the devolved administrations, are working with partners across the UK’s research system to identify measures to strengthen the UK’s research base and life sciences sector, in a programme on clinical research Recovery, Resilience and Growth (RRG). NIHR has worked in partnership with the research funders, the devolved administrations and other stakeholders in a national Managed Recovery programme to ensure targeted support enables rapid recovery of selected studies across a range of conditions and builds on the success of research and learnings during the pandemic. Together, this work supports the vision set out by the Department of Health and Social Care in the document Saving and Improving Lives: the future of UK clinical research delivery. However, further action is necessary.
In response to the ongoing challenges in research delivery, the Department of Health and Social Care (DHSC) has introduced the Research Reset programme with the aim of making portfolio delivery achievable within planned timelines (time and target) and sustainable within the resource and capability we currently have in the NHS. It aims to free up capacity across the research system, by working with funders and sponsors to support the review of studies that have already completed, or that are unlikely to be able to deliver their endpoints in the current environment. The programme is led by DHSC, with input from an advisory group including representatives from industry, medical research charities, NHS Research and Development, research delivery workforce representatives across NHS settings, patient and public representatives, medical Royal Colleges, universities, the Medical Research Council and NHS regions across the UK.
DHSC and NHS England and Improvement have outlined the expectations of sponsors and funders, in particular on them to review their studies, with a view to focusing on those studies that can reliably deliver results. DHSC has asked the NIHR to assist with data provision and maintenance of the data integrity of the portfolio during this process.
NIHR is collating the data provided by funders and sponsors, to identify lists of studies that meet certain criteria indicating a study may be suitable for review and action. This will be shared with funders and sponsors, who can then take appropriate steps. This could include closure in line with HRA guidance, or provision of more up-to-date data, should currently-listed data be inaccurate. Slow recruitment due to a study serving the needs of a rare disease will also be taken into consideration. Funders and sponsors are expected to work with and involve study participants, their patient communities and other stakeholders throughout the review process. This Research Reset programme builds on the work undertaken in the Managed Recovery programme and all studies in that programme are in scope for this review.
During the Research Reset programme, NIHR will continue to accept new studies onto the portfolio, in line with current criteria. However, study sites are being asked to reconfirm that such studies really can be delivered in the current circumstances.
Further information on the Research Reset programme can be found on the website for the UK Clinical Research Recovery, Resilience and Growth programme. The site is managed and hosted by NIHR on behalf of all of the Programme partners.