The NIHR Clinical Research Network (CRN) has convened the NIHR Urgent Public Health Group (UPHG) to provide clinical intelligence for the selection, prioritisation, set-up and delivery of studies relating to COVID-19. The group discuss strategic clinical issues and not operational delivery issues, which are addressed through study specific meetings.
The primary purpose of the UPHG is to address the items listed below:
- Review studies submitted for Urgent Public Health (UPH) designation and provide recommendations to the Department of Health and Social Care (DHSC).
- Support ongoing UPH studies through provision of clinical intelligence
- Provide a mechanism for specialty experts to input into UPH studies, including identification of a lead clinical contact for each study
- The remit of this group extends to all areas of the UK and as such membership from the Devolved Nations (DN) has been sought.
- Commercial and non-commercial studies will be evaluated
- feedback for commercial studies will be provided by the Business Development and Marketing Team directly to the sponsor.
- Only studies that are funded from an eligible funding source and require access to CRN resources will be evaluated.
- Urgent Public Health remit is defined as: COVID-19-related research that requires access to CRN resources to facilitate the delivery of research during emergency phases of the pandemic. Impact is to be delivered within a timeframe relevant to this pandemic and includes:
- Collection of samples and data from patients and staff in hospitals and care settings
- Mental Health where there is a life-threatening risk
- Meetings are convened as often as needed from 5:00-6:30pm.
- Papers are provided ~24 hours in advance, although given the fast paced nature of the situation it may not always be possible to adhere to this requirement.
- Lead reviewers are nominated and informed 48 hours in advance of the meeting.
Studies will be evaluated against the following criteria:
- How compelling is the science underpinning the proposed study?
- Is it feasible to deliver in the current environment of the NHS and social care?
- Is the study of appropriate scope and scale for National Priority status?
- Is the funding appropriate to deliver the proposed outcomes of the study?
- Is there an appropriate management plan to avoid interference with recruitment to other Urgent Public Health studies?
- Will results be relevant to this pandemic?
Where decisions are to be taken in respect to recommendations to DHSC, a minimum quorum for this group will be representation from 50% of the represented specialties, one member of the represented MedTech and In vitro Diagnostics Cooperatives (MICs), one member from each of the DNs and one member of the Research Delivery Directorate, deputies have been requested from these members and have authority to act on behalf of the person they are deputising for.
Should a vote be required for decision making, decisions will be made by a vote from the Specialty Lead, MIC, Clinical Trials Network and DN representatives with the Chair having the casting vote.
Decisions are forwarded to the Scientific, Research and Evidence (SRE) Group by the UPHG secretariat. The expectation is that the SRE Group and Chief Medical Officers (CMO) office will respond within 2 working days.
Chief Investigators (CIs) will be notified of the decision following CMO confirmation of the UPHG recommendations.
The UPHG will allocate a National Clinical Link (CL) to each study designated as UPH.
The Research Delivery Directorate also has an allocated Research Delivery Link (RDL), this individual will provide the personal point of contact for the CL.
CLs will be the main clinical point of contact for the NIHR CRN Research Delivery Directorate (RDD) and Lead LCRN on a per study basis, and will be the CRN team’s first point of escalation for set up and delivery issues and challenges. Likewise, the CL should ensure that they liaise with the RDD regarding any study queries or concerns that they become aware of. To facilitate this collaborative approach to supporting the study, the RDD team will ensure that the clinical link is invited to key discussions and study-related meetings, and is kept up to date on progress with the study.
The role of the CL is to support activities throughout the lifecycle of the study by offering clinical expertise; specific support required will be based on the needs of the individual study.
Strategic Portfolio Oversight
The UPHG undertakes a weekly review of the UPH portfolio via a process of Strategic Portfolio Oversight (SPO). SPO involves reviewing a selection of studies together, grouped by, for example, setting/study design/participant type, in order to learn from challenges or successes within those particular groupings. This ensures that any lessons learned are heard in a timely manner and can be acted upon across the Network at speed to support effective delivery of the UPH portfolio.
A list of members is published. New members will be identified as needed.