The National Institute for Health Research (NIHR) has set out a framework for the resumption of non-COVID-19 health research that has been paused as a result of the coronavirus pandemic.
Since the pandemic was declared, the NIHR has been at the forefront of international research efforts to find effective new treatments for COVID-19. Working with partners, the NIHR has moved at extraordinary speed to prioritise, fund and support a pipeline of high-quality, ‘rapid response’ research including the RECOVERY trial – the largest global therapeutic trial in COVID-19 with over 10,000 patients recruited.
The UK is now entering a new phase of the pandemic, with the number of new cases declining, the suspension of some ‘surge’ capacity in the NHS, and the resumption of some routine elective NHS care.
The time is now right to work towards restoration of a diverse and active portfolio of NIHR research, and to restart the setting up of new research including that delivered through the NIHR’s Clinical Research Network and Clinical Research Facilities. It’s also appropriate to support individuals who have paused NIHR career development awards to resume clinical academic and research roles.
The framework is designed to support the restoration of a broad portfolio of NIHR research which aims to improve the health and wealth of the nation. It is being delivered following extensive consultation with NIHR partners and stakeholders, and provides a structure to guide local decision-making by sponsors, funders, investigators, site R&D directors and others.
Work to restart studies will be complementary to ongoing work on urgent public health COVID-19 studies, which will continue to be given high priority due to their vital importance to the overall national and international response to COVID-19. As a result, local support from NIHR’s Clinical Research Network and Clinical Research Facilities may need to be prioritised in some cases.
The framework also makes clear that research should only start or restart if it is viable and safe to do so. Inevitably, the pace of restart will have to be in line with the capacity and readiness that local health and care services are able to provide. The NIHR will centrally monitor the restart process across England to help identify and resolve any issues that may arise.
The Framework applies to England, but has been developed in consultation with representatives of the devolved administrations, who may themselves publish analogous guidance in due course.
Dr. William van’t Hoff, Chief Executive of the NIHR’s Clinical Research Network, and Senior Responsible Officer for the NIHR Restart Programme said: “We know taking part in healthcare research is good for patients and good for the NHS, so it’s right that we make sure research can be resumed as soon as NHS or care services are able to restart across the country. The framework will deliver this, while making sure that detailed decisions on when and how to restart are made by local clinical leaders who understand the current pressures on their health and care systems.”
Aisling Burnand MBE, Chief Executive of the Association of Medical Research Charities (AMRC) said: “Clinical research is not only vital to the development of new treatments and an improved understanding of diseases, for many patients, it is a crucial lifeline. We welcome NIHR’s ‘Restart Research Framework’, which will help get the nation’s clinical research back up and running, reigniting hope in patients across the UK.
“Together we will restore the UK’s world-class clinical research base to ensure the continued delivery of innovative treatments for patients while playing a critical role in the UK’s economic and social recovery.”
Dr Sheuli Porkess, Executive Director, Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) said: “This framework is a key first step in restarting clinical trials that have been paused due to COVID-19. It’s critical that vital scientific research can continue so that new treatments can be developed for patients.
“The health of patients must be our priority. The pharmaceutical industry will continue to work in partnership with the NHS and the Government to get the UK’s research ecosystem back up and running.”