Transitioning clinical trials at GOSH
20 May 2023, 7 a.m.
At GOSH we run hundreds of clinical trials each year, many of which take place in our dedicated facility - the National Institute for Health and Care Research (NIHR) Great Ormond Street Hospital (GOSH) Clinical Research Facility (CRF).
The state of the art, purpose-built facility allows researchers from across the hospital, and the UCL Great Ormond Street Institute of Child Health (UCL GOS ICH), to undertake clinical research alongside our specialist team of research nurses, play specialists and dedicated non-clinical research team.
While many clinical trials may begin in the NIHR GOSH CRF, at various stages that may need to move from our dedicated facility into the clinical wards around the hospital. But, transitioning a study from the NIHR GOSH CRF into the standard clinical pipeline requires a lot of careful planning and specialist training for new teams.
That’s why at GOSH, we have the UK’s first dedicated Research Hospital Transition Lead Nurse – Waffa Girshab - to bridge the gap between research and clinical care. Waffa dedicates her time to identifying suitable trials for transition, working with the research nurses to plan transitions, training new clinical teams about research practise and monitoring transitioned trials.
Transitioning trials from the NIHR GOSH CRF into wards across GOSH is fantastic opportunity for us to grow our research capacity as hospital. It allows us to run more studies, as well as to introduce more of our staff to research and clinical trials. For patients, research trials can be very intensive and often the move back into standard clinical care can be daunting. By transitioning trials, it gives families a chance to make this switch in a more gradual way.
A new role to build our Research Hospital vision
The Research Hospital Transition Lead Nurse position was developed at GOSH after the Research and Innovation team worked with staff to understand their thoughts on the early transition of studies into clinical care.
In her role, Waffa provides research expertise and advice across GOSH on how to transition clinical research studies safely and efficiently into routine clinical practice.
Transitioning clinical trials into clinical care settings also increases research access for many families, reducing the extra commitment required from participants in research studies including travelling to specialist appointments or attending specialist clinics alongside their standard clinical care.
Transitioning at the end of a trial
Some trials start in the NIHR GOSH CRF and meet their “end-points” in the dedicated unit too. However, even after a successful trial it can take time for treatments to be formally approved by regulators and to become part of standard NHS care.
In 2014 the UK Government set up the Early Access to Medicines Scheme (EAMS) that helps to give people with life threatening or seriously debilitating conditions early access to new medicines where there is a clear unmet medical need but the treatment does not yet have full marketing approval.
For some children at GOSH, this scheme has meant that they are still able to access life-changing treatments they may have received on clinical trials while they wait for them to be approved.
Lumasiran is a new treatment for the rare condition Primary Hyperoxaluria Type 1 that affects around 90 children in the UK. The NIHR GOSH CRF treated children on its clinical trial from 2016 all the way through to its successful end point. In the summer of 2020, Lumasiran became part of the EAMS, allowing children from the trial to continue accessing treatment while regulators formally approved the drug.
While the NIHR GOSH CRF was the perfect place to run the trial, once the EAMS status had been granted the treatment needed to be moved out of the facility. So, our transition team worked closely with staff on Possum Ward to bring the medicine into their clinical practise. They supported the team to understand how the new treatment worked and needed to be delivered while ensuring they were trained to undertake the close safety monitoring required for new treatments on this pathway.
As well as transitioning families from the NIHR GOSH CRF once trials have finished, the team are now working to understand when trials can be moved part way through data collection. The hope is that this will further build capacity in the NIHR GOSH CRF as well as developing research awareness and skills in staff across the hospital.
Recently, Waffa led a team to do just that for the first time at GOSH. Anna Ryan, Research Nurse in the NIHR GOSH CRF, worked closely with Hannah Chaffe, a Clinical Nurse Specialist, in the Neurology outpatient's department to run a Phase 3 open-label extension study in her clinical service.
It was great to work with the Neurology team on this transition. We had to work closely with Hannah to ensure that not only could she deliver the treatment but that she understood all the clinical governance and tracking that comes with running a clinical trial. This is very different to day-to-day clinical practise and so it’s great to see more of our GOSH staff learning these skills.
It was really rewarding to take part in the transition of this clinical trial into our outpatient’s service. I loved learning all of the new research skills and can’t wait to look for further opportunities to get involved in research!
Continuing to learn and build
The team have now taken their learnings from the initial clinical trial transitions and have developed formalised patient pathways and processes for future transitions. They are working on a process to rapidly identify new trials that can transitioned from the NIHR GOSH CRF to clinical care in the hospital or even to local hospitals around the country.
They hope that this role will support the mission to embed research across the NHS and provides more patients and families access to new and novel treatments.
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