The emergence of the COVID-19 pandemic in early 2020 led the NHS to suspend many routine clinical services and the NIHR to prepare to support the Government’s research response. Subsequently, the decisions taken in March 2020 by research sponsors, funders, investigators and study sites to pause some non-COVID-19 research, and by the NIHR Clinical Research Network to pause set up of new sites or studies, other than for nationally prioritised COVID-19 studies, led to a rapid and significant reduction in NIHR research activity.
In May 2020, the NIHR published a Restart Framework 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. Our goal is to restore a fully active portfolio of NIHR research while continuing to support important COVID-19 studies as part of the Government response to the pandemic.
Since May, we have seen a steady and progressive improvement in the number of studies and study-sites that are now open, both commercial and non-commercial. Recruitment to studies has been both complex and challenging but there are good examples of sites applying the framework and getting non COVID-19 research up and running alongside the recovery of clinical services.
Examples of the framework in action
Study viability: How a digital approach is enabling studies to reopen in Leicester
This Trust developed a collaborative process that provided people with an opportunity to input into the viability of a study, and discuss any changes that needed to be made to how a study is delivered.
Safety: Moving research forward remotely
How this postponed observational study managed to open, carrying out risk assessments and utilising
Capacity and site readiness: Restarting research in Nottingham
A Restart Group was set up at this Trust to explore which studies were possible to reopen, this included a review of linked clinical services and capacity assessments.
This research team had to balance the risks of COVID-19 against the benefits of trial therapies in patients with unmet needs in lymphoma.
To help share how sites are overcoming challenges in restarting research, Local Clinical Research Networks are publishing news stories and case studies to highlight where progress is being made, key learnings and best practice.
Keeping patients safe
We have been working to assure patients and the public that it is safe to attend research appointments, following feedback that anxiety around potential COVID-19 exposure might be putting people off visiting healthcare settings, particularly for research appointments which might be seen as non-essential.
Using insight from patient focus groups and feedback from frontline settings, we have produced new resources setting out what action has been taken to keep people safe in their research appointments.
The Be Part of Research website has been updated with this information, there is also a video, short animation, poster and leaflet templates which can be tailored for local use. Please contact your Local Clinical Research Network communications team for PDF and InDesign files.
For further information:
- If you have questions about the pausing or restart of a clinical study: firstname.lastname@example.org
- If you are a patient or member of the public and have been recruited into a research study, please contact your study team or visit our Be Part of Research website.
- If you are from a company wanting to be connected to the NIHR's expert researchers: email@example.com
- If you have questions about career development award funding including fellowships: firstname.lastname@example.org
- If you have questions about programme funding: either email@example.com (i4i, PRP, PGfAR, PDG, RfPB and RIGHT) or firstname.lastname@example.org (EME, HS&DR, HTA, PHR, ESP, CTU support funding, HSPR and global health units and groups)
- If you are part of NIHR's broader research infrastructure or a school or unit: email@example.com
- NIHR Restart Framework
- First update on implementation of the Restart Framework
- Second update on implementation of the Restart Framework
- Third monthly update on implementation of the Restart framework
- Fourth update on implementation of the Restart Framework
- NIHR issues final update on implementation of the Restart Framework
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.
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.