Clinical Research & the CRTU
The Consultant team in the Elsie Bertram Diabetes Centre is the most research active directorate in this large University Teaching Hospital and offer a substantial range of expertise and in depth support for academic and industry associated studies.
Since the original diabetes research unit (DRU) opened in 1995 the diabetes team have undertaken more than 70 research studies with industry, or externally funded with local and UK collaborators. This research unit has now moved to the purpose built NHS Clinical Research and Trials unit.
The research team is highly experienced in clinical trial recruitment, GCP, participant retention, eCRF and database management, and in dealing with the regulatory pressures and obstacles in clinical research in the UK. The directorate is also very closely linked with the Eastern Region Diabetes Local Research Network and Norfolk and Suffolk Endocrinology and Metabolism Comprehensive Local Research Network (weblinks).
We are aware of the intense recruitment pressures that many industry studies require, and are committed to realistic and accurate recruitment estimates, and have recruited to target in all industry and academic studies in the last decade.
Recruitment sample sizes have ranged from up to 6,000 – 8,000 sample size for some studies (Norfolk Diabetes Study, UEA – IFG etc), with 10,000 planned for NDPS down to small numbers in highly specialist trial recruitment and intense recruitment effort.
- Recruitment locally is supported by excellent research working relationships with local practices individually and through PCRN support.
- Clinical Research & Trials Unit operating over 2 sites at NNUH & UEA, lead by experienced research management team.
- Expert research team – GCP trained.
- Expert study recruitment and retention team
- 6 Bedded day ward at NNUH & 8 clinical examination rooms at UEA site
- Dedicated participant parking at UEA site.
- CRTU database manager
- Trials Research Monitor
- Experienced trial pharmacy team
- Pharmacy holding room at UEA site
- Dexa scanner (prior arrangement with UEA)
- 2 preparation rooms (1 at each site) each containing centrifuge
- Meeting room at UEA site
- Fridge, -40 and -80 freezers at NNUH site and fridge, -20, -40 and -80 freezers at UEA site (all monitored electronically every 15 mins with alarm systems in place)
- Participants dining area at UEA
- Secure office space for storage of site files
- Lab facilities
Diabetes Research Network staff
- Louise Jones – DRN Lead Diabetes Research Nurse
- Claire Brennan – band 6 Diabetes Research Nurse
- David Tomlinson – band 6 Diabetes Research Nurse
- Tracey Gray – band 6 Diabetes Research Nurse
- Professor Mike Sampson – EoE Deputy DRN lead
- Suzanne Hamblin – DRN administrator
In addition there are 15 research staff (RA / Research Nurse / research staff etc) working on diabetes projects outside DRN contracts.
Patient identification and selection process
There are an estimated 42,000 people with diabetes registered in 90 NHS Norfolk practices, and PHO modelling suggests this will rise to 70,000 by 2030. Of this population, 3800 are followed in the Elsie Bertram Diabetes Centre (EBDC), Norfolk and Norwich University Hospital and are mostly T1 or insulin treated T2D patients.
The EBDC has effective databases to allow recruitment searches (Dendrite; Diabeta 3) and substantial databases for coronary disease outcomes (MINAP; Dendrite) and for paediatric, foot care and antenatal clinic activity which are among the largest in the UK.
The EBDC has had strong research links with local primary care since the development of the GP diabetes research group in 1998, and recruitment for diabetes studies is largely through practices supported by long established recruitment strategies supported by DRN and PCRN and coordinated from CRTU by DRN staff. This model has delivered effective large volume recruitment over the last decade (Warren/NDS/EDIT/UEAIFG/NDPS/Progene etc) and also targeted project grant and industry recruitment.
Information for Patients
If you are interested in diabetes research or taking part in research please discuss with your normal diabetes team, whether in primary or secondary care.
How to find us
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Information for Clinical Staff or Researchers
If you are a clinician in training, or a researcher, interested in working in Norwich, or are interested in clinical trial placement, please contact us on one of the numbers below, or contact Professor Mike Samspon (01603 287094) or Louise Jones – Senior Diabetes Research Nurse ( email: firstname.lastname@example.org)