Clinical Research in NUTH during a second wave of COVID-19
I am writing to update you on how clinical research are responding to this second wave of COVID-19 and to outline our approach for the coming months. I know how challenging things are at the moment, trying to balance our clinical and research responsibilities, and am very grateful for your time and efforts.
Firstly, it is important to remember that the majority of studies which are currently open and recruiting in the Trust are in disease areas other than COVID. Of the 4000 participants recruited in the Trust since 1st April, 60% were recruited into non-COVID studies, including participants into ‘priority 1b’ studies which remained open and recruiting during lockdown. Over the last few months research teams, working with colleagues in the Joint Research Office, have managed to safely restart the majority of the studies paused during the first wave, as well as open 50 new studies. I know the work that has been required to do this, developing local solutions, adapting operating procedures and amending study protocols. This non-COVID research is no less important because of the pandemic and we are keen that these studies remain open and recruiting wherever possible.
With case numbers increasing over the last few weeks, the COVID research team are actively recruiting to six interventional and ten observational studies in clinical areas across our organisation. We are also setting up COVID studies to run out of the NIHR Patient Recruitment Centre (formerly P3 Unit) on the CAV site. The COVID research team is been actively managed to ensure that we retain the experience and expertise from the first wave, have sufficient staff to maintain a manageable workload, yet without depleting the other delivery teams – as you can appreciate this isn’t always easy and I am very grateful for your support and understanding.
Coronavirus vaccine studies have been and will continue to be a high priority for research in the Trust. The Oxford Vaccine Study (COV002) recruited very well, helped by the excellent facilities in the Clinical Research Facility at the RVI. However, the CRF has other important work to do and I’m delighted to say that we have secured some much needed clinical research space on Ward 11 at the Freeman Hospital. This is currently being developed into a dedicated research ward, with the next vaccine study due to open there in early November.
In line with the Trust’s approach to clinical services during a second wave, we are keen to continue our broad portfolio of clinical research and continue to recruit to studies where it is safe to do so. We will do all we can to support researchers to maintain their clinical research activity over the coming months, while acknowledging that COVID studies remain an urgent public health priority.
In terms of local R&D approvals, we plan to continue to process these are we have done since the first wave of the pandemic. This approach worked well, relying on the Clinical Research Leads and Team Leads to know their own portfolio, to prioritise which new studies they wish to restart/set-up and to work within the capacity of their delivery team. In some cases, where capacity is restrained, teams may decide to submit a study to the JRO that things can be ready for when the team is back to a full complement. In contrast, during this second wave, we are keen to avoid pausing/suspending any research studies, unless there really is no other option. In such cases we would aim to do so on study-by-study basis after careful consideration.
I can assure you that a lot of work is going on behind the scenes to bolster the clinical delivery teams, including the advertisement of various fixed term positions and the recruitment of bank staff, to support COVID studies. Some temporary ‘juggling’ will remain necessary in the short term. During the first wave of the pandemic a number of our nurses volunteered and/or were redeployed to help in frontline clinical roles. There were many positives to this and we were proud to see our research staff stepping up to help out but inevitably it did deplete our workforce. As described above, the context now is very different, with an imperative to both deliver the COVID/vaccine studies and to support the non-COVID studies which have safely continued, restarted or opened during the pandemic. As a consequence, we will avoid redeploying staff to clinical areas unless there is no other option. This position is supported by guidance issued this week from the NIHR https://www.nihr.ac.uk/documents/nihr-guidance-for-a-second-wave-of-covid-19-activity/25837
Clearly, it is hard to predict how things will look in a few weeks time and while case numbers appear to be plateauing, if they increase dramatically, we may need to revise our plans. While we wait to see how things unfold I hope this provides a useful overview of the current situation.
If you have any questions or comments please contact any of us in the senior research leadership team and we will do our best to help.
Dr Stephen Wright | Clinical Director R&D