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COVID-19 and Research Trials

National Priority Framework for Clinical Trials & Research Studies

From the start of the COVID-19 pandemic, UHDB has been supporting a significant number of Coronavirus trials. UHDB is the highest recruiting Trust in the East Midlands for 3 of those studies and it was identified as the nationally leading Trust for recruitment to the SIREN study in a recent report. Since May, we have been reviewing and reopening non-Covid studies to which recruitment was paused in March.

As we face an increase in the number of Coronavirus cases, the NIHR has released a statement regarding the prioritisation of research studies and trials over the coming weeks. UHDB will be following this national priority framework for the set-up of new studies and recruitment to trials.

Dr William van't Hoff, Chief Executive of the NIHR CRN, has provided the following information:

“In the context of increasing COVID-19 cases and admissions to hospitals, I am writing to highlight a decision from the CMO, and approved by the Secretary of State, on prioritisation of NIHR infrastructure support for research".

The three levels of prioritisation set out within the Restart Framework still apply, with some prioritisation within Level 1 to identify the highest priority COVID-19 UPH studies:
 

  • Level 1a (Top Priority) - COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP).
  • Level 1b - Other COVID-19 UPH studies.
  • Level 2 - Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.
  • Level 3 - All other studies (including COVID-19 studies not in Level 1a or 1b).
     

The three UPH platform studies in Level 1 are prioritised to really boost recruitment so as to rapidly achieve the primary outcome measures for the current interventions which will provide very important evidence. The VTF-prioritised vaccine studies are clearly vital to conduct as soon as possible.

Dr Louise Wood, Director of Science, Research and Evidence at DHSC and co-lead for NIHR added:

I appreciate the fantastic job thousands of research staff have been doing over several months in very difficult circumstances (both at work and in their personal lives) and recognise that, despite huge commitment and resilience from the research delivery workforce, R&D office staff and the NIHR, the capacity in the system is finite. We are reaffirming the priorities set out in the Restart Framework, and specifying COVID-19 UPH vaccine and prophylactic studies and platform therapeutics trials as the top priority for research infrastructure support.

UHDB R&D would like to thank everyone who has supported us during the COVID pandemic, from our Clinical colleagues throughout the Trust, Pathology for COVID19 testing, The Blood Transplant team for advice on convalescent plasma, IT colleagues and everyone who has taken part in the SIREN study.