NIHR shares first update on implementation of the Restart Framework
On 21 May 2020, the NIHR published a Framework for the restarting of research paused due to the impact of the COVID-19 pandemic. This was intended to provide a structure to guide the restarting of a full range of NIHR research, while maintaining local decision-making and flexibility.
The framework proposes a one month period for sponsors and sites to conduct preliminary assessments of paused studies, starting with assessments of study viability. It indicates that study prioritisation should not take place until after assessments have occurred and only if NIHR-funded support is required.
Dr William van't Hoff, CEO of the NIHR Clinical Research Network (CRN) and Senior Responsible Officer for the Restart Programme said: “It’s been just over a month and we are seeing good progress in terms of assessments taking place and paused research being restarted in parallel with the restoration of routine clinical services. We recognise the key workforce challenges, the continued pressure on NHS services in many areas of the country and the practical difficulties faced by patients, but I am confident we will continue to make headway in terms of restarting research.
“This is our first update and we plan to share more information via the NIHR website on an approximately monthly basis, including restart data, case studies, best practices and, if needed, updates to the framework.”
The latest data
According to CRN data received from 207 out of 223 NHS Trusts, 174 Trusts (84%) have non-COVID studies open to recruitment as of 1 July 2020, up from 57% at the height of the pandemic.
The Network also has data on 3,906 non-commercial studies (79% of the non-commercial portfolio) that were open or in set-up during the acute phase of the pandemic. As of 1 July, 55% of these studies are paused, down from 70% at the peak; 26% are open for recruitment, up from 12% at the peak. Only 1.3% (51 studies) have had to close due to COVID-19. We are aware of 461 non-commercial studies that have restarted since the height of the pandemic.
Commercial studies were much more likely to remain open than non-commercial studies, even at the peak of the pandemic, mostly because a higher proportion were interventional trials.
One challenge has been that, when assessing study viability - an essential step prior to restart - sponsors are sometimes waiting for sites to confirm while sites are waiting for sponsors to confirm.
- Key industry partners including the ABPI, BIA and ACRO have advised that the default position for sponsors of commercial studies is to restart their studies. Sites can therefore proceed to assess the other pre-conditions outlined in the framework (safety and capacity/ site readiness) in order to inform the sponsor of their readiness to restart.
- AMRC and non-commercial funders also support the prompt restart of studies so long as they are deemed viable at site level. If studies are able to restart without the need for a protocol amendment or study extension, studies may proceed to assessment of other pre-conditions. They urge all studies requiring a protocol amendment to liaise with their funder on requirement to re-open studies.
- NIHR also supports the prompt restart of studies funded through NIHR programmes. If the Chief Investigator and sponsor determine that there is no need for a protocol amendment or study extension of more than six months or additional funding, studies may proceed to assessment of other pre-conditions. In all other cases, studies should liaise with their NIHR Research Programme monitoring contact.
The NIHR recognises that there are constraints to restart such as the return of staff seconded to work in the frontline in the NHS, and furloughed staff in some academic institutions and charities. Where research staff are no longer essential to providing COVID-19 care, it is our expectation they will be released to return to their research role as early as possible. This is particularly important given the need to support nationally prioritised Urgent Public Health research into COVID-19 and to prepare for large-scale vaccine studies.
We are also aware of the need to build confidence among patients and the public that researchers will put in place changes to help protect patient safety when taking part in research. As a first step, we have updated the copy on our Be Part of Research and Join Dementia Research sites. It will also be important for sponsors and researchers to work with potential study participants on study design, to build in changes that would make it easier, more convenient and more reassuring for patients to take part from the outset.