York and Scarborough Teaching Hospitals NHS Foundation Trust has a long history of working with Industry and Clinical Research Organisations (CROs) to deliver research studies successfully and to a high standard.
We are committed to having an Industry portfolio that is appropriate in both complexity and variety to march our Trust's geographical population and size. Most of the studies we participate in take place at our three larger hospital sites: York Hospital, Scarborough General Hospital and Bridlington District Hospital.
Our previous Industry experience ranges from working on observational drug monitoring and disease impact studies to those using medical devices and Investigational Medicinal Prodcuts. We have collaborated with Industry on Phase II to Phase V studies and each year we continue to build upon out performance and portfolio.
- 2019 saw our Trust successfully gain HSE Class 1 premises clearance to enable us to run studies involving Genetically Modified Organisms.
- 2021 saw us embark on our first large scale Phase II commercial vaccine trial.
- 2022 will see the introduction of a Commercial Research Manager to the team who will continue to build lasting links with Industry partners and develop our portfolio further.
Industry acknowledgements and notable achievements
- Over the past 5 years the Trust has Sponsored 7 Industry funded or supported, single and multicenter studies in the following areas: Ophthalmology, Perioperative care and ICU, Dentistry and Gastroenterology.
- Our participation in Arquer 006 contributed to the recruitment of 84 patients across North Yorkshire which was almost double that of the specified target.
- In 2019 we undertook our first independent GMO vaccine, Phase 2, Class 1 study for patient undergoing Kidney Transplantation. Our previous experience of GMO vaccine trials has been through collaborations with our associated Medical School/University.
- The PuraStat® post-market study into a device used to manage bleeding in vascular surgery patients recruited nearly triple the noted target within a 9-month period.
- The Trust collaborated with the company "Health Navigator" to test an innovative new telephone-based care management system in the Emergency Department; enrolling 832 participants.
- We were the highest recruiting site in the UK for the SAFARI study that collected outcomes from patients with macular degeneration who switched between two medications.Over the past 5 years alone we have achieved the first UK recruit for the following studies:
ASCEND-ND - A study for those patients with Chronic Kidney Disease and anaemia. A new oral drug was compared to an existing injectable treatment.
ARIADNE - A cardiology observational study looking into real world care of Heart Failure Patients.
EXIST III - Investigated the used of a new drug for patients with tuberous sclerosis complex (TLC) and refectory seizures. We continued to participate in the rollover study.
PARALLAX - Investigated the use of study drug for Heart Failure patients with co-morbidities.
POLAR M - Explored the use of study drug in addition to chemotherapy for patients with metastatic colorectal cancer to assist with the prevention of peripheral neuropathy.
- Successful delivery of the Phase 3 COVID-19 vaccine trial COVLP-021, recruiting to target with 54 healthy volunteers. Utilised local and regional media to support the campaign, and delivered at a newly setup, trial-specific Vaccine Hub at the University of York by the R&D Department.
Our current Trust performance data can be viewed here
Our Research Workforce
- We have more than 100 experienced Principle Investigators in the Trust. To support their research interests we have a dedicated team of Research Nurses, Clinical Trials Assistants and Research Practitioners that are all managed by 3 Senior Research Nurses. Our research workforce has a robust and varied skill set each with their own areas of specialism.
- We have a dedicated Pharmacy Clinical Trials Team run by 5 staff members, each with appropriate qualification. The facility has their own office, temperature-controlled storage, dispensing facility and access to research experienced Pharmacists.
- We have 3 Laboratory Research Associate Practitioners that are embedded in the Trust's core Laboratory Medicine Department, including histology, biochemistry, microbiology and haematology, and work closely with these to meet study protocol requirements for set up and processing samples.
- We also regularly engage with the Trust's Radiology and Cardio Respiratory Departments to secure and organise protocol related activity.
Research and Development has its own Quality Assurance Manager (QAM) that oversees the Trust's portfolio of research.
- The QAM provides quarterly Quality Reports, and internal monitoring and audit of studies.
- All of our Research Workforce have research CVs, full NIHR GCP, and NIHR consent training (where required) that they keep up to date and filed.
- The QAM also monitors the training of staff via an automated Standard Operating Procedure (SOP) system called Q-PULSE.
- We can provide on-site facility for Sponsors and CROs wishing to complete Monitoring Visit activity.
- We use a mixture of both paper and electronic source data for verification both of which can be accessed by Sponsors and CROs in line with R&D SOPs.
- Upon archving, studies are sent securely off site to our contracted archive facility at which our QAM completes periodic audit.
If you would like us to conduct preliminary feasibility or if you have any other questions about collaborating with York and Scarborough Teaching Hospitals NHS Foundation Trust, please contact our Commercial Research Manager.
Dr Marthe Ludtmann