NIHR Clinical Research Facility
The NIHR Clinical Research Facility (CRF) at Guy’s and St Thomas’ plays a vital role in the translation of experimental research into patient benefit and is an important NIHR infrastructure associated with our BRC. The CRF comprises five units: a Medicines and Healthcare Regulatory Agency (MHRA) Phase I accredited adult unit within Guy’s Hospital; adult and imaging units located within St Thomas’ Hospital, a paediatric unit within the Evelina London Children’s Hospital at St Thomas’ Hospital; and a cardiorespiratory unit within the Royal Brompton Hospital. Each unit has specialist state of the art infrastructure to conduct a wide range of interventional and observational trials across a broad range of disciplines.
The MHRA accredited Phase I unit is co-located with the BRC’s Advanced Therapy Manufacturing (GMP) platform providing a seamless transition between manufacture of autologous cell therapies to patients within the Phase I unit. Early phase oncology studies are widely supported within the Phase I unit, including trials of cell therapies including CAR-T and TIL therapies for solid tumour cancers. The adult unit within St Thomas’ allows for the conduct of high throughput cardiovascular, nutrition and vaccine trials in both patients and healthy volunteers. The imaging unit is fully integrated within the clinical service and houses the pan-London ultra-high field 7T MRI. The paediatric unit (Seal and Wolf wards) has been specifically designed to deliver paediatric clinical trials including those for children with neuro-disabilities; the Wolf ward hosts early phase and advanced therapy paediatric trials. The Cardiorespiratory unit within the Royal Brompton houses negative pressure treatment rooms supporting trials involving the administration of inhaled investigational medicinal products.
The CRF supports both non-commercial and commercial clinical trials. The unit has strategic partnerships with many of the major pharmaceutical, biopharmaceutical and medical device multi-national companies (including AstraZeneca, GSK, Medtronic, Pfizer. Philips and Siemens). Trials from many UK SMEs as well as those from spin-out companies from guy’s and St Thomas’ and King’s are delivered via the CRF (including Leucid Bio and Epsilogen).
- The T4 phase I trial utilising CAR-T cell therapy to treat solid tumour head and neck cancer is delivered within the Phase I unit by the unit’s nurses, clinical research practitioners and laboratory staff. The trial is ongoing but has shown that the therapy is safe in 13 patients when given as an intratumoral dose (Papa, S. et al., 2018, Journal of Clinical Oncology 36, no. 15_suppl: 3046)
- The MOv18 study Phase I trial, utilising first in class chimeric IgE antibodies for the treatment of solid tumours, was hosted within the Phase I unit. The study showed that the treatment was safe with preliminary data showing anti-tumour efficacy (Spicer, J. et al., 2020, Proceedings: AACR Annual Meeting)
- The Learning About Peanut Allergy (LEAP) study was delivered within the paediatric unit and assessed the impacts of consumption of peanut allergen at a young age on the development of peanut allergy later on in childhood. The study showed that the early introduction of peanut allergen in early childhood decreased the risk of developing peanut allergy and that this tolerance lasts for at least a year. (Du Toit, G. et al., 2018, J Allergy Clin Immunol, 141(4): 1343-1353)
- The adult unit at St Thomas’ delivered the PREDICT study which investigated responses to standardised and non-standardised test meals and has shown that predictions can be made on personalised food responses as a result of the individual’s metabolic characteristics. (Mazidi, M., et al., 2021, American Journal of Clinical Nutrition, 114(3): 1028-1038)
- The EXTEND study, supported through the Royal Brompton unit, investigated the long term safety, tolerability and efficacy of a Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator, Tezacaftor-ivacaftor in patients with a specific CTFR mutation. After 96 weeks, trial data showed that Tezacaftor-ivacaftor was generally safe, well-tolerated and efficacious and therefore had long term clinical benefit for cystic fibrosis patients aged 12 or over with the mutation (Flume, P. et al., 2021, The Lancet Respiratory Medicine: 9(7): 733-746)