NIHR issues final update on implementation of the Restart Framework
The NIHR published a Framework on 21 May 2020 - when the NHS started to restore routine clinical services - to support the restarting of research paused due to COVID-19. Developed in partnership with multiple stakeholders and the devolved nations, the Framework provides a flexible structure for local decision-making.
We’ve seen steady progress since that time with 69 percent of studies that were paused now restarted and 60 percent of these recruiting participants. However, given the huge surge in COVID-19 cases and the emergence of variants, we know that this performance will be difficult to maintain where routine care on which research relies is delayed, or capacity to support non-COVID studies is limited. Rather than recommending a national ‘pause’ of new studies as we did in Spring 2020, we are advising that such research is supported as possible in line with the Restart Framework.
Dr William van't Hoff, CEO of the NIHR Clinical Research Network (CRN) and Senior Responsible Officer for the Restart Programme, said: “Given the pressure the NHS is under, our focus right now has to be on urgent public health research into COVID-19, including delivery of prioritised vaccine studies and platform therapeutics trials. However, we are actively collaborating with research system partners to ensure that non-COVID research can quickly regain momentum as and when things ease up in the Spring.”
The latest CRN data
As of 20 January 2021, our data indicate that since the Restart Framework was published:
- 69 percent of both commercial and non-commercial studies that were paused have restarted
- 60 percent of previously paused studies have recruited participants
- 1,103 new studies have been added to the NIHR CRN Portfolio
- 268 of these new studies have opened to recruitment and 174 have recruited participants
- Of the 2,310 studies that were never paused, 1,750 are open to recruitment and 120,934 participants have been recruited
Looking to the future
Going forward, NIHR is playing its part as one of a group of key partners working to take coordinated action to recover non-COVID research and to build a better and more resilient clinical research delivery system for the future. Our partners include DHSC, the devolved nations, the Office for Life Sciences, NHS England and NHS Improvement, NHS Digital, NHSX, the regulatory authorities (HRA and MHRA), industry and medical research charities.
Future updates will focus on this sector-wide programme of work.
Restarting NIHR programme studies
During this difficult period of time, we have maintained contact with leaders of non-COVID studies, trials and projects funded through NIHR’s research programmes and learned how they have adapted in order to continue. We found examples of those already planning online trials being able to resume relatively quickly. For others, where possible, protocols had been updated and received approval to continue through lockdowns, in some instances converting to online or remote formats in place of in person. Lack of access to labs has, however, caused some delays, such as when externally procured components incurred longer lead times.
Organisations across the research infrastructure have shared guidance to aid research delivery in the context of the pandemic. Below is a list of examples:
- FPM Clinical Trials Resilience Survey – Report Published
The Faculty of Pharmaceutical Medicine Survey was implemented between October and November 2020. It sought to understand the pressures and adaptations that its members have experienced, and to learn whether the COVID-19 pandemic has brought about permanent changes to pharmaceutical medicine and drug development and regulations that could or should now become integrated into ‘normal’ practice.
- Guidance for Clinical Trial Units
Guidance for CTUs from the UKCRC Registered Clinical Trials Units Network.
- NHS R&D Forum Resource Exchange
The Exchange aims to share practice and provide support in all the essentials of running health and care R&D Departments across the UK.
- MHRA Blog: Building resilience into clinical trial design and conduct during the pandemic
Updated guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19.
- NHS England and Improvement Blog: Supporting nursing research and evidence to underpin policy dialogue and system transformation.
Guidance from the Health Research Authority:
- Implementing a temporary halt to all or some of the study
- Re-opening studies or sites that have been paused
Latest stories from the Local Clinical Research Networks, highlighting where progress is being made, key learnings and best practice:
- Southampton develop innovative solution for remote monitoring during coronavirus
- Researchers praised for their efforts in restarting research in south London
- Lockdown no barrier to Sarah's research participation
Further resources are available on the ‘Restarting research’ page, including links to previous updates, examples of best practice and resources to help reassure patients that it's safe to get involved in research, like this short animation.