The Oxford Health Clinical Research Facility (OH CRF) is the only CRF in the UK supported by the National Institute for Health and Care Research (NIHR) which is entirely dedicated to mental health. Set up in 2011 with Professor John Geddes as Director, it was also the first NIHR-funded infrastructure at Oxford Health NHS Foundation Trust. Most recently in 2022, OH CRF was awarded £4.1 million from the NIHR to continue its pioneering work in improving mental and cognitive health treatments through clinical research over the next five years.
A growing and diverse portfolio and staff skills to match
The OH CRF runs approximately 30 trials at any one time, with around 25 members of staff. The portfolio is diverse, with commercial and academic-led studies covering dementia, depression, bipolar disorder, schizophrenia and post-traumatic stress. The OH CRF also has specialised rooms for sleep studies.
There is a fundamental challenge in mental health which OH CRF is working to address, according to Professor Andrea Cipriani, OH CRF Director since 2019:
“With many mental health treatments, there is limited understanding of the mechanisms by which they work and how they might be targeted or personalised to individual patients,” he explains. “This is why it’s so important to have a clinical facility embedded in the NHS and dedicated to high intensity studies, where we can conduct the necessary procedures with enough trained staff on hand to support patients through the process.”
To work at OH CRF, staff need to be skilled in both supporting mental health patients and physical health interventions that might be required for a particular trial. This is an unusual mix, as OH CRF manager, Claudia Hurducas explains:
“Nurses rarely have a background in both mental and physical health, so our training addresses this,” she says. “We try to ensure all relevant staff have the full range of skills they need, including in laboratory work and in less intensive interventions, such as taking blood, Electro Cardiograms (ECGs), etc. This allows us to deploy staff flexibly to respond to all trials in the pipeline. For more invasive procedures, such as lumbar punctures, we collaborate locally with colleagues from other disciplines to exchange knowledge and expertise.”
Sometimes study protocols will demand that only particular professionals are able to carry out certain interventions. OH CRF will negotiate this with the sponsor if needed, to ensure not only that the trial itself is feasible but that the treatment, if proved successful, could feasibly be implemented across the NHS. This was the case recently in a trial using psychedelics, where the protocol required clinical psychologists or psychiatrists to carry out all steps of the treatment.
“Currently there is significant interest in the potential of psychedelics, but as a clinician working in the NHS, I must consider: can they be integrated and implemented at scale into clinical practice?” says Andrea. “We’re piloting something new, thinking ahead in terms of translational pathways, which includes training nurses and research assistants with a psychology background to deliver these treatments in real-world settings.”
Other innovations that Andrea is bringing into OH CRF include time working at OH CRF as part of their rotation for junior doctors, and to offer voluntary secondments for overseas medics and psychiatrists in training under the supervision of Dr Katharine Smith, OH CRF Clinical Lead. Both of these initiatives leverage external resources and increase the number of medical staff that the CRF can draw on for its studies.
Working across the Oxford healthcare innovation ecosystem and beyond
Partnership working across Oxford has been in place since OH CRF’s inception and was significantly strengthened during the Covid-19 pandemic. Although OH CRF had to stop its research (the whole world stopped in Spring 2020), the facility and the staff were redeployed to manage the Covid-19 vaccine trials.
“We randomised hundreds of patients for those trials. During that time we learned a lot from our colleagues working in physical health and we also managed to recruit our current CRF Matron, Amanda Colston!” recalls Andrea. “This experience helped us build our relationship with the Experimental Medicine Clinical Research Facility (EMCRF), based at Oxford University Hospitals (our local acute Trust), and this relationship continues to thrive today.”
Some studies are now run across both Oxford CRFs, including a recent trial of a therapy (an antisense oligonucleotide), injected into the fluid-filled space between the thin layers of tissue that cover the brain and the spinal canal, as a treatment for dementia. The first visits and intrathecal injections were planned to take place at the EMCRF, drawing on the expertise of medics there, with follow-up visits at OH CRF and OH CRF staff on hand at all times to deal with the mental health needs of the study participants.
Oxford Health Trust leads the NIHR’s Mental Health Mission (MHM), which is also focused on bridging the gap between experimental medicine discovery and implementation, to ensure that treatments can be delivered into clinical practice. The OH CRF works together with projects across the MHM to help ensure the smooth set up of studies, involving dedicated staff with both clinical and governance expertise.
Claudia chairs monthly meetings with the managers of the other NIHR-funded infrastructures at Oxford Health and their counterparts at OUH and colleagues from the Mental Health Mission are regularly invited to join these meetings to help ensure alignment across different partners.
The collaboration extends beyond Oxford to neighbouring mental health trusts in Avon and Wiltshire, and Berkshire, which OH CRF supports in mental health research and training.
Vision for the future
In the last thirteen years, OH CRF has developed from basic beginnings to a specialist facility with calm and relaxing outdoor spaces and dedicated areas for sleep and psychedelic studies. Despite this ongoing and successful growth, Andrea still has plenty of plans for the future.
One pressing need is the requirement for more space, with the current facility at capacity with over 90% occupancy. Andrea is working with the Trust towards a larger, purpose-built research facility in the planned Warneford Park development to be located close to new hospital wards.
“We’ve developed an amazing facility here despite challenges with the building,” he says. “There is significant interest in mental health research worldwide and a huge unmet need to develop new treatments. We’ve shown that we can bring studies in and generate the income. If we had more space, co-located within the hospital and closer to patients and clinicians, there is so much more we could do.”