Managing research recovery

The COVID-19 pandemic led the NHS to suspend many routine clinical services and the NIHR to support the Government’s research response. The focus from March 2020 to March 2021 has been to support the priority Urgent Public Health COVID-19 studies, which have led to the development of new treatments and vaccines, and generated evidence that has underpinned the response to the pandemic. Whilst research into other conditions continued, it was severely affected by a reduction in capacity and accompanying NHS services.

With the pressures of the pandemic beginning to ease and COVID-19 caseloads falling, work is underway to support the recovery of research into other conditions, and to increase the strength of the UK’s research base and life sciences sector. This 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.

NIHR is working in partnership with the research funders, the devolved administrations and other stakeholders in research in a national 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.

Sequencing of studies

There are over 6,000 studies on the NIHR Clinical Research Network portfolio. The UK’s health and care system and its staff need time to recover from the enormous impact of the pandemic. There is a large backlog of clinical care to support as well as a large number of research studies to restore to full activity.

The Department of Health and Social Care has asked NIHR to work with research funders and partners across the UK’s research system to develop a plan to manage the recovery of those studies that require support over the next 6-12 months.

We are working with funders, NHS R&D, research partners across the UK and patients and the public on a process to manage the recovery of multi-site studies . Operational plans are being finalised and further details will be published here. In outline:

  • The scope is interventional, multi-site clinical research studies that are urgent and require the support of NIHR CRN and its Devolved Administration equivalents. The initial focus will be on studies which can fully recruit and/or close in the next year, although we appreciate particular specialities may need a different approach and will require some flexibility where appropriate.
  • Funders will identify the most urgent studies, and then research delivery teams will work with Local Clinical Research Network teams and R&D leadership to discuss and assess site, regional and national delivery capacity and capability.
  • As the process develops, National Specialty Leads will review their portfolio to identify other studies that may fall into scope.
  • Further rounds of review may be needed, as and when the first set of studies are recovering towards normal recruitment.
  • This process will begin immediately and will aim for support to be directed for the first tranche of studies in a phased manner within the next few weeks.

Studies which are already open and recruiting successfully should not be paused in anticipation of, or as a result of, this process. Other studies which fall outside of the scope should continue to be managed as usual by local sites.

NIHR CRN will continue to accept new studies but their delivery will need to be balanced alongside managed recovery of existing studies on the portfolio.

The sequencing process is a tapered transition, with the number of selected studies ramping up as capacity becomes available. It is envisaged to be for a limited time period of 6-12 months, until there is sufficient capacity that it is no longer necessary.

Restart Framework
(now superceded)

How research continued during the pandemic

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 videoshort 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.

Contacts

For further information:

  • If you have questions about the pausing or restart of a clinical study: crn@nihr.ac.uk
  • 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: nocri@nihr.ac.uk
  • If you have questions about career development award funding including fellowships: academy@nihr.ac.uk
  • If you have questions about programme funding: either ccf@nihr.ac.uk (i4i, PRP, PGfAR, PDG, RfPB and RIGHT) or netsmonitoring@nihr.ac.uk (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: ccf@nihr.ac.uk

External links

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
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.