NIHR shares third monthly update on implementation of the Restart Framework
On 21 May 2020, the NIHR published a 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.
Dr William van't Hoff, CEO of the NIHR Clinical Research Network (CRN) and Senior Responsible Officer for the Restart Programme, said: “We know that the past few months have been very difficult for patients keen to be on research studies and for researchers and organisations keen to see their life changing research resume. We are working hand-in-hand with the NHS to support the restart of studies as clinical services are restored. Each week we see a higher proportion of studies that have restarted, although we appreciate the challenges for patients attending for research. We’re gathering not only quantitative data but also best practices to enable peer-to-peer learning, and developing tools to help sites reassure patients that they can once again get involved in research.”
The latest CRN data
CRN continues to improve its data collection and the following is our best currently available intelligence.
As of 9 September, 45% of studies (2,676) are open to recruitment, with a further 17% in the set-up / follow-up stage of activity and proceeding as planned. Fifty seven percent of commercial studies (878) and 40% of non-commercial studies (1,798) are open. Of the 2,676 studies that are open, 36% have recruited since 1 June - 24% of commercial studies and 42% of non-commercial studies.
Sharing best practice
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. NIHR would like to thank these sites for sharing their experience.
Keeping patients safe
NIHR has 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 a new resource in the form of web copy, a leaflet and, in the future, short films, setting out what action has been taken to keep people safe.
The Be Part of Research website has been updated with this information, which is also available in a leaflet template which can be tailored for local use. This can be found on the NIHR communications site, or is available from email@example.com.
The importance of sponsor monitoring
An inability for sponsors’ monitors to attend research sites has been identified through the Restart Advisory Group and other reports as an important barrier to restarting life science studies. The R&D Forum and UKRD conducted a survey which indicated that only 40% of Trusts are allowing on-site monitoring and many of those only for selected studies. Some Trusts have a blanket ban on external visitors and industry sources report significant problems accessing data remotely from NHS Electronic Health Record systems.
NIHR has discussed the issue with NHS England, stressing the importance of study monitoring in ensuring patient safety in studies and encouraging transition and improvements to remote monitoring systems.
An update on NIHR programme research
Restart continues across NIHR programmes as clinical academics return to research following their work on NHS recovery. Adjustments have been introduced at several universities to enable safe access to essential support services including analysis labs, and amendments have been made to some research plans and study protocols - for example face-to-face consultations have been transitioned to online formats. Revisions to research protocols are being agreed with regulatory bodies and NIHR programmes with the changes formalised as necessary through contract variations.
For other projects, material changes are being made to care pathways which will delay the revision of research plans and the restart of studies. Research in settings such as schools and care homes remains challenging. Using data provided by CRN, we are monitoring the number of studies recruiting new participants and the number of participants recruited to those individual studies. Restarted studies are joining the portfolio of research projects which were never paused due to the pandemic.
Clinical academics returning to research
NIHR Academy Members have continued to be supported to return to their research roles following guidance which outlined the aim of this taking place by 5 August. Encouragingly, the majority of NIHR Academy Members have now returned to their research and clinical academic roles.
One clinical academic who has now returned to their research role after almost four months working on the front-line is Christine Comer, a physiotherapist and NIHR Clinical Lecturer. In a recent case study Christine has shared her experiences and how she has found returning to her research role.
In addition to the support being given to NIHR Academy Members and their host institutions, we are also working with Health Education England and Higher Education Institutes to develop guidance and principles for any future requirement to return to clinical work in the event of health emergencies, pandemics or a further wave of COVID-19 occurring.