Update on clinical research during the COVID-19 outbreak

UPDATE 7 APRIL 2020:

Approval process for COVID-19 related research

Locally, trials and studies need first to be reviewed by the Cambridge BRC/Covid-19 oversight committee before being submitted through the national NIHR prioritisation mechanism.

All COVID-19-related research studies are being prioritised at a national level through the NIHR. Studies seeking approval should first apply through the NIHR gateway, with nationally prioritised research being signposted for an expedited regulatory approval with the HRA/MHRA.

Email Covid19research@addenbrookes.nhs.uk for more information about undertaking COVID-19-based research studies at CUH.

Continue reading previous update (dated 19 March 2020):

As part of our response to COVID-19, some of our research activity will need to change.

We are reviewing all of our clinical research with Cambridge University Hospitals (CUH) and the University of Cambridge. Each study is being assessed on a case-by-case basis to minimise risks to participants either from continued participation in or disruption to a trial that forms part of their clinical care.

Some studies will need to pause or wind down to release staff for clinical roles and sample processing infrastructure to support the NHS.

Principal Investigators:

Chief and Principal investigators should review their studies and assess the risk to participants posed by COVID-19. Following risk assessment, please confirm your proposed mitigations or actions with Professor John Bradley, Director of Research, as soon as possible.

Research Participants:

Research participants will be contacted by their study team with updates about any changes to the study they are enrolled in. Please contact your study team if you have any further questions about your study or your participation during these events.  Participants who believe they have COVID-19 symptoms should follow Department of Health and Social Care advice and contact their study team.

Patient and Public Involvement (PPI):

CUH is committed to supporting the research effort against COVID-19, and patients and the public will have a particularly valuable role as we embark on this.  The PPI team are working remotely, but are still available to speak to researchers who need assistance with PPI for their grant applications or documentation reviewed by the CUH PPI panel. Our panel has over 70 people who are willing to review research-related documents and this service is still available, with our panel members very committed to continuing their support for researchers during this period.

Non-essential visits to the campus are not permitted at this time. As such, we have cancelled all in-person meetings and training that were planned through to the summer. This will continue to be reviewed as the situation changes. All filming and work experience in our research buildings have been suspended/ cancelled due to the current restrictions in place.

The PPI and communications team are also investigating options to run their training sessions and other PPI activities online.

If you need any assistance contact the PPI team: cuh.ppi@nhs.net