The COVID-19 pandemic will lead to significant demands being made of clinical services and inevitably this will impact on clinical research in the Trust. The scale of the demands on clinical services in uncertain but there is likely to be significant disruption of research activities. The situation is also dynamic and advice from the Government and other national agencies can change rapidly. Our clinical research portfolio is large and includes the full spectrum of research activity, from Phase 1 studies to health services research and from international CTIMPs to small PhD projects. To manage this portfolio, we’ll need the support of all investigators and research delivery teams and a collaborative approach which is clear, flexible and pragmatic. It is also important to have a consistent approach across the research platforms, research delivery teams and pharmacy. Our aims during the pandemic should be to ensure the safety of patients and staff, to prioritise our research studies and target our resources accordingly, to maintain high standards of research governance and, where needed, enable research staff to support clinical services.
Trust policy, procedures, advice and information
All clinical research staff will follow Trust information and advice for all issues related to the COVID-19 pandemic, including Trust policies and procedures for infection control, occupational health and HR. The latest Trust information regarding is available via the COVID-19 banner on the intranet and daily updates will be provided from Trust Communications.
Given the rapidly changing situation, a daily StarLeaf call has been scheduled for Team Leads, JRO and Pharmacy colleagues to receive information, discuss capacity, ask questions etc. That call is 10am on a Mon, 1230 Tues-Fri. The most up-to-date research-specific advice will still be sent via email (from either Norma Smith or Jackie McDonald) and posted on the NJRO website. In the last few days there has been useful information provided by the MHRA and HRA.
Prioritisation of studies
Local Principal Investigators and research delivery teams are requested to prioritise their open studies using the criteria below. Prioritisation will provide a useful overview of the whole portfolio of research studies and a framework for rationalising the workload of the research teams. While this process should be straightforward for most studies it is inevitable that some trials might not fit neatly in the classification, in these cases we would encourage investigators to choose the best fit.
Studies investigating COVID-19 including emergency public health studies.
Studies where a patient’s treatment depends on them being in the trial, e.g. early-phase cancer trials where the treatment is only available in the context of a trial and ‘usual care’ options are ineffective.
Studies where there is a safe and effective ‘usual care’ treatment option for patients not enrolled in the trial, e.g. a RCT of novel antihypertensive versus standard care, or a device study where an alternative device or treatment option exists.
Observational, qualitative, bio-bank and other studies.
Staged action plan
We have developed a staged, action plan, to provide a structure for managing the impact of the pandemic on clinical research in the Trust. As of the 16th March 2020 we are at Stage 1. This will be reviewed daily bearing in mind the demands on the research delivery teams and support services (laboratories, pharmacy and radiology), the demands on the clinical services, and the need to free up research staff to help support clinical care. Investigators and research teams will be notified of any changes and the actions required.
Please visit our dedicated COVID-19 updates article to view the latest version of the R&D action plan.