Greater Manchester: Research support and guidance on the impact of COVID-19 on research funded or supported by NIHR

CRN Greater Manchester: COVID-19 impact

Restart Framework

The NIHR has published a Restart Framework to guide the restarting of NIHR research activities which have been paused due to COVID-19.

Contacting CRN Greater Manchester

If you wish to contact NIHR CRN Greater Manchester with any queries, please do so via our usual contact address, which is being monitored as usual: researchsupport.crngm@nihr.ac.uk

We have also created an online COVID-19 notification form if you want to make us aware of any issues which have arisen as a result of the virus in relation to the Open Data Platform (ODP).

Greater Manchester Clinical Research Awards 2020

The Greater Manchester Clinical Research Awards 2020 have unfortunately been cancelled due to the coronavirus pandemic.

It is still our intention to honour the work of our network, particularly in light of the fantastic response to the outbreak, in a different way and further details will be confirmed at a later date.

Training

All CRN Greater Manchester face-to-face training has been cancelled until further notice.

Our Workforce, Learning and Development Lead has provided full details of the interim arrangements and advice.

Getting a study nationally supported or funded as high priority COVID-19 Urgent Public Health Research

Government support is available to prioritise, coordinate and deliver these studies, regardless of sponsorship and funding source.

This support includes expedited identification of sites to ensure appropriate geographical distribution of Urgent Public Health Research to maximise recruitment and minimise over-commitment of resource.

To be considered for this support, please follow the Department of Health and Social Care review process.

Urgent public health research studies for COVID-19

The Department of Health and Social Care has classified a number of studies as urgent public health research expedited studies. Further information on all studies has been provided on the NIHR's COVID-19 website.

Recording delays

The data recording system, R-Peak, now has a new functionality which allows Trust R&I teams to record/capture research delays caused to NIHR Portfolio studies by COVID-19.

Our Head of Information Management & Technology has provided full details.

Latest NIHR statements

Update on implementation of the Restart Framework- 3 July

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.”

Read the full update.

Supporting the restart of paused NIHR research activities - 21 May

We are entering a new phase of the pandemic, where the number of new cases of COVID-19 is declining and we have a significant portfolio of nationally prioritised urgent public health studies which are actively recruiting participants. The time is right to work towards the restoration of a diverse and active portfolio of research funded and/or supported by the NIHR - including both non-COVID-19 research and important COVID-19 research which does not meet our urgency criteria.

To help initiate this process, the NIHR has developed a ‘Framework for restart’ , which is a guidance document to support local decision-making. Read more.

Chief Medical Officers write to NHS trusts about recruitment to COVID-19 studies - 6 May

We are still lacking proven, effective, treatments for Covid-19, but the UK is well placed to develop evidence to inform future patient treatment. Clinical trials are critical both to determining which treatments work and developing the evidence for safety, frequency and dose. This letter is to request your help. There are several complementary trial platforms across the range of severity. As new admissions fall due to the success of social/physical distancing measures it will become even more important that a high proportion of patients with Covid-19 are enrolled onto trials if we are to improve future treatment. We highlight here RECOVERY and ACCORD.

Thanks to the work of clinicians in many hospitals RECOVERY, which tests several drugs in hospitalised pre-critical patients has recruited at a remarkable pace, and at this point has over 9000 participants enrolled. RECOVERY is designed to detect even modest effects on survival. To obtain strong evidence requires large numbers e.g. 2000 participants per arm. If we can keep recruitment for RECOVERY high, above 1000 patients per week, we could have answers on some treatments in 5 weeks. This will allow us to move successful drugs into routine care. Currently enrolment to RECOVERY is at 13% of all admissions. We appreciate that the operational pressure from Covid-19 makes research hard, and local situations will lead to variability in ability to recruit, but increasing this proportion is important.

The Health Secretary recently announced ACCORD https://www.gov.uk/government/news/covid-19-treatments-could-be-fast-tracked-through-new-national-clinical-trial-initiative to facilitate smaller Phase II trials of 20-60 participants to test newer therapeutics. Experimental medicine early phase studies are being conducted via four platforms, one of which is ACCORD. These will work together, with promising drugs being considered for inclusion in the existing larger Phase III
platform trials (PRINCIPLE, RECOVERY, REMAP-CAP). We expect recruitment for the early phase studies to be focused on more specialist centres across the UK, especially those with Biomedical Research Centres in England or centres in the devolved nations with experience of such trials.

Other priority studies are listed here https://www.nihr.ac.uk/covid-19/urgent-public-health-studies-covid-19.htm. A lot of other valuable research is being undertaken across the health and care system. It is important that this other research continues, subject to it not having a negative impact on the system’s ability to recruit participants and provide the resources needed to support priority clinical studies. If you have any concerns or comments about the clinical trial landscape for COVID-19 therapeutics or are running an early phase trial not part of the above, please get in touch through
the new Therapeutics Taskforce, which can be reached at therapeuticstaskforce@dhsc.gov.uk.

Thank you again for your work so far. Improving treatment in the future is critical for our response to this new infection.

Dr Frank Atherton, Chief Medical Officer for Wales / Dr Catherine Calderwood, Chief Medical Officer for Scotland / Dr Michael McBride, Chief Medical Officer for Northern Ireland / Professor Chris Whitty, Chief Medical Officer for England / Professor Stephen Powis, National Medical Director for NHS England and NHS Improvement

Prioritising funding and support for COVID-19 research across the UK - updated 27 April

Working with partners across the health and care system, the NIHR is funding, enabling and delivering world-class COVID-19 research, a key element of the Government’s overall response to the pandemic. Given the extraordinary pressures currently being faced by the health and care system, we are also ensuring that best use is made of the limited resources and capacity available to support research and that there is no duplication of effort.

We have established a UK-wide portal for applying for funding and/or prioritised support for urgent COVID-19 research. Central to the prioritisation process is a UK-wide expert panel, reporting into DHSC and acting on behalf of the Chief Medical Officer / Deputy Chief Medical Officer for England, which designates the COVID-19 studies that hold the most potential for tackling today’s challenges as Urgent Public Health Research. This expert panel reviews funded studies, irrespective of whether they are funded by the public sector, industry or charities.

Studies which do not yet have funding are assessed by an independent panel, supported by a college of experts, which makes funding recommendations to DHSC and UKRI.

With regard to HRA approvals, researchers who make an application through the portal are signposted for expedited regulatory review so that this can progress in parallel to the system of assessment potentially leading to Urgent Public Health Research designation.

All NHS Trusts, health and care providers and universities are expected to prioritise support for Urgent Public Health studies.

Where studies do not require either funding or NIHR Clinical Research Network support, they do not need to go through the portal and can proceed in accordance with business as usual processes. However, they must not have a negative impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support Urgent Public Health national priority studies. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.

Read the Q&A document on the prioritisation process for Urgent Public Health Research.

It is recognised that there are studies which are very important but do not need to take place during the emergency phase of the pandemic. These should not be submitted through the portal for Urgent COVID-19 research. The NIHR is exploring alternative ways to process non-urgent but vital COVID-19 studies.

New information for the public on COVID-19 research

NIHR has updated its resource for patients and the public, the Be Part of Research website, with new information and links about COVID-19 and research underway into the condition.

Postponement of Be Part of Research 2020 campaign - 7 April

Dear Partners,

Just a few weeks ago we shared an initial briefing with you, outlining our plans to raise awareness and interest in public participation and involvement in research through our annual ‘Be Part of Research’ campaign.

This was due to begin in May to coincide with International Clinical Trials Day (ICTD) on 20 May. Regrettably we have decided that it is not appropriate to go ahead with the 'Be Part of Research' campaign we had planned. We will, however, mark International Clinical Trials Day via our social media channels.

No new date for the campaign has been set and we are thinking through how best to proceed with this campaign as well as the Your Path in Research campaign, planned for the autumn. We will need to take into account national, NHS and NIHR priorities and resources and the time needed for national and local teams to plan campaign delivery.

We realise that many teams will have already started planning for ICTD and some have contributed to the national campaign planning with case studies and other support. Thank you so much for this - your contributions will not be wasted - and we hope that we will be able to count on your support again when the time is right.

Please note that we are temporarily closing our online print shop so you will not be able to order leaflets, posters and merchandise for the time being. However, when it is appropriate to do so, we will reopen it, even outside the campaign period.

Thank you for your support to date and we wish you well in the weeks ahead.

Kind regards,

Chelsea Drake

Head of Communications, NIHR Clinical Research Network

A letter to all UK NHS trusts on the importance of COVID-19 Clinical Trials, from UK Chief Medical Officers and NHS England National Medical Director - 2 April

Dear colleagues,

Novel Coronavirus: Clinical Trials

We are writing to ask that every effort is made to enrol COVID-19 patients in the national priority clinical trials; there are trials in primary care, hospital settings and ICUs.

As yet, there are no proven treatments for Covid-19. We need to gather reliable evidence through clinical trials. Using international evidence and UK expertise the most promising potential treatments, at this stage, have been identified and the UK is running national clinical trials to gather evidence across the whole disease spectrum.

The key three national trials are:

PRINCIPLE (higher risk patients in primary care trial). www.principletrial.org

RECOVERY (in hospital trial) https://www.recoverytrial.net For further information please email: recoverytrial@ndph.ox.ac.uk

REMAP-CAP (critically ill patient trial) https://www.remapcap.org For further information please email: ukremap-cap@icnarc.org

Other priority studies, including observational studies, are listed here - https://www.nihr.ac.uk/covid-19/urgent-public-health-studies-covid-19.htm

These trials are being run as simply as they can to reduce the burden on the NHS, with adaptive designs so further treatments can be added if new promising candidates are identified. The results are essential to the future treatment of UK and global patients. We will ensure important results are disseminated rapidly to improve practice.

The faster that patients are recruited, the sooner we will get reliable results. While it is for every individual clinician to make prescribing decisions, we strongly discourage the use of off-licence treatments outside of a trial, where participation in a trial is possible.

Use of treatments outside of a trial, where participation was possible, is a wasted opportunity to create information that will benefit others. The evidence will be used to inform treatment and benefit patients in the immediate future.

Any treatment given for coronavirus other than general supportive care, treatment for underlying conditions, and antibiotics for secondary bacterial complications, should currently be as part of a trial, where that is possible.

Best wishes,

Prioritising funding and support for COVID-19 research across the UK - statement 26 March

Working with partners across the health and care system, NIHR is leading, enabling and delivering world-class COVID-19 research, a key element of the Government’s overall response to the pandemic. Given the extraordinary pressures currently being faced by the health and care system, we must also ensure that we are making best use of the limited resources and capacity available to support research.

We will do this by establishing and implementing a single, national process that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.

This process will cover funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.

Details of the process and the new single point of entry for prioritising COVID-19 studies are now published.

With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.

All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies is being collated.

Organisations may support COVID-19 research activity only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.

COVID-19 studies are only priority - Statement 19 March

Until further notice, the NIHR Clinical Research Network is pausing the site set up of any new or ongoing studies at NHS and social care sites that are not nationally prioritised COVID-19 studies.

This will enable our research workforce to focus on delivering the nationally prioritised COVID-19 studies or enabling redeployment to frontline care where necessary.

These studies are enabling the clinical and epidemiological evidence to be gathered to inform national policy and will enable new treatments, diagnostics and vaccines to be developed and tested. The complete focus of the NIHR Clinical Research Network will be on delivering these highest priority COVID-19 studies.

During this time, the MHRA and HRA will continue to provide an approvals service for all studies, prioritised in accordance with the national situation, ensuring site set-up can restart promptly in due course.

Department of Health and Social Care / NIHR statement - 16 March

In response to COVID-19, Dr Louise Wood CBE, has issued the following statement. Dr Wood is Director of Science, Research and Evidence at the Department of Health and Social Care and co-lead for NIHR.

Working with partners across the health and care system, NIHR enables and delivers world-class research that transforms people's lives, promotes economic growth and advances science. This is why the NIHR community must prioritise nationally-sponsored COVID-19 research activity, a key element of the Government’s overall response. We urge all parts of the research system to help progress these studies at pace.

Many of our community who drive or deliver NIHR research also provide direct care to patients and the public. Given the scale of the national and global challenge of COVID-19, clinical and academic health & care professionals currently funded by NIHR who are working on topics other than COVID-19 should prioritise frontline care, where requested to do so by their employing organisations. Similarly, research staff with other relevant skills, such as pharmacists and laboratory technicians, should also prioritise support to frontline care. In addition, researchers should consult with their employers to make facilities which currently support research studies available for frontline care.

This will mean that many research studies funded by NIHR, or supported by NIHR (via the Clinical Research Network and other NIHR infrastructure) may need to be paused, to free up NIHR-funded staff to help bolster the frontline response to COVID-19. In addition, we recognise that NIHR award-holding organisations may need to pause research studies for locally determined public health reasons.

However, clinical trials or other research studies which are funded or supported by NIHR should continue if discontinuing them will have significant detrimental effects on the ongoing care of individual participants involved in those studies. These are clinical decisions which will need to be made on a case-by-case basis by local decision makers on the basis of local risk and capacity assessments.

All organisations holding NIHR awards that are paused will, in the short term, continue to receive payments from DHSC in line with existing NIHR contractual payment schedules. This will be reviewed and if necessary, payment schedules will be updated as usual following the annual statement of expenditure. Where necessary, contract deliverables will be rescheduled allowing staff to concentrate on frontline care and COVID-19 research.

Any individuals or organisations funded by and/or supported by a particular NIHR funding stream who have further questions should contact their relevant NIHR Coordinating Centre in the first instance. Your usual contacts will apply but, if in any doubt, please get in touch via the contact points outlined below.

Q&A on this topic can be found here. We will update this advice periodically in response to future developments.

Finally, may I thank you for the efforts you are already making to support COVID-19 research and your response to the needs of the health and care system during these extraordinary times.

Dr Louise Wood CBE

Director of Science, Research and Evidence at the Department of Health and Social Care and co-lead for NIHR.

Contact points for further information:

If you are in receipt of career development award funding including fellowships: academy@nihr.ac.uk

If you are in receipt of 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 have questions about the delivery of a clinical study: crn@nihr.ac.uk

If you are part of NIHR's broader research infrastructure or a school or unit: ccf@nihr.ac.uk

If you are a patient or member of the public and have been recruited into a research study, please direct any questions to your study team