Gastroenterology Clinical Trials Facility
The Gastroenterology Clinical Trials' Facility is a purpose-built three bed, day case facility for conducting clinical trials in Gastroenterology. It is located within the extended Endoscopy Unit on level 2 of the John Radcliffe Hospital (commissioned Q4 2009), directly below the basic science laboratories of the Translational Gastroenterology Unit and the clinical ward on level 5.
There is a strong tradition of experimental medicine and clinical research in Oxford Gastroenterology, since Sidney Truelove conducted the first ever clinical trial in Gastroenterology in 1955 of corticosteroids for the treatment of ulcerative colitis. Oxford is extremely well placed to conduct clinical trials at a local, national and international level, owing to well defined patient populations and internationally known Gastroenterologists specialising in inflammatory bowel disease and hepatobiliary medicine.
Highlights for Gastroenterology and Hepatobiliary clinical trials in Oxford
- Well-defined patient cohorts in ulcerative colitis, Crohn's disease, coeliac disease, primary sclerosing cholangitis, short bowel syndrome, hepatitis C, hepatitis B, primary biliary cirrhosis
- Large catchment population (620 000 secondary care, tertiary referral centre, total 14500 outpatients and 12500 endoscopies/ year) providing ready access to patients with common gastrointestinal disorders other than the chronic disease cohorts, including irritable bowel syndrome, peptic ulcer disease, gastroesophageal reflux disease and sphincter Oddi dysfunction
- Integrated service with colorectal, upper gastrointestinal, hepatobiliary and transplant surgical units, with involvement in novel surgical therapies including bariatric surgery and small intestinal transplantation
- Integrated clinical service and basic science, with expertise in mucosal immunology, proteomics, T-cell and Paneth cell function, allowing 'value added' research to clinical trials by examining biomarkers or mechanisms of action, either in vitro or ex vivo
- Potential for in-house development of novel therapeutics, devices, and techniques providing a stream for early phase trials
- Well established links with global decision makers in Pharmaceutical companies at both clinical and scientific levels
- International representation by members of the Unit on NICE committees, the Board of the European Crohn's and Colitis Organization Scientific Committee (www.ecco-ibd.eu); as Chief Investigators of more than 10 clinical trials and developing new metrics for measuring trial outcomes
- Location within the Endoscopy at the John Radcliffe Hospital, juxtaposed to outpatients and directly below the ward area and laboratories (both clinical and basic science)
The CTF has two sources of income from studies:
2. UK Clinical Research Network (UKCRN) 'Portfolio' studies, through the Thames Valley local clinical Research Network (contact Morag.Burton@orh.nhs.uk, TV CLRN Industry Manager 01865 226640)
If interested in any of these, contact us on 01865 221187 or firstname.lastname@example.org
For patients with mild-moderate active Crohn's disease. The aim of this international study is to determine whether high dose mesalazine (6g/day) is an effective treatment alternative for active Crohn's disease. Other medical treatment (including steroids, or azathioprine) is not increased.
For patients with mild-moderate active ulcerative colitis. The aim this sham-controlled, international study of leucocytapheresis is to determine whether this blood filtering device that removes activated inflammatory cells, is effective for treating active ulcerative colitis, without other medical treatment.
For patients within 3 months of surgical resection for Crohn's disease. The aim of this national UK study is to determine whether mercaptopurine prevents recurrence of Crohn's disease after resection.
For in-patients with acute severe ulcerative colitis. The aim of this national UK study is to determine whether infliximab or ciclosporin is more effective for colitis that is not responding to intravenous steroids
For patients with severe, active Crohn's disease. The aim of this international study is to determine whether autologous stem cell transplantation is effective for severe Crohn's disease that has not responded to conventional or biological therapy (either infliximab or adalimumab).
For patients on adalimumab for Crohn's disease. The aim is to document the consequences of treatment with adalimumab over an extended (5 year) period.
For patients with Primary Biliary Cirrhosis. The aim is to test a novel treatment (INT-747) with and without ursodeoxycholic acid. Study continues, but closed to new recruits.
An extended genome wide association study in coeliac disease
For any patient with coeliac disease. The aim of this study being lead by Professor David Van Heel in London, is to collect genetic material (a sample of saliva), so that DNA can be extracted and genotyped to determine susceptibility to gluten sensitivity (coeliac disease). This can be arranged by post.
Clinical trials administrator: Jo Hovard, email@example.com
Research Sister: Madeleine Thyssen 01865 221187, firstname.lastname@example.org
Lead clinician: Dr Simon Travis 01865 228753, email@example.com