Two CCRN-supported hepatology trials
Primary Biliary Cirrhosis (PBC) Genetics and Primary Sclerosing Cholangitis Studies
Hepatology Specialty Group
The PBC Genetics Study is a national effort to establish a PBC DNA collection consisting of DNA samples from approximately 5000 patients with PBC. The study looks for variations in small fragments of DNA between 'healthy controls' and patients. The DNA collection will be used for a genome-wide association study (GWAS) of PBC and future genetic studies. Recruitment started in Cambridge, expanded to include East Anglia and transplant centres, and is now recruiting nationally. Getting the CCRN on board made an enormous difference to getting more participants into the study. We now have a co-ordinator in Cambridge who directs nurses around the country to identify patients and collect data, which he then collates. Recruitment in the fourth year of the study is now running at 60 - 100 patients a month with total recruitment at over 4,000 which (with about 12000 - 15000 patients recruited nationally) is staggering.
Clinical Trials Update #4 March 2011
The national GI and Hepatology Specialty Groups are keen that:
- interested clinicians are encouraged to recruit patients and also have access to the NIHR CCRN infrastructural support.
- any blocks to trial recruitment are highlighted: These can be fed to your local CLRN GI or Hepatology Specialty Group Lead(see link below) or to the Chairs of the Groups: Stuart Bloom (Gastroenterology) or Steve Ryder (Hepatology).
Anyone wishing to become involved in clinical trials will need to attend an on-line or in-person course on GCP (Good Clinical Practice). These are usually free from your local R&D Dept. Also see useful links below. Advice on trial set-up can be obtained from trial coordinators and local R&D teams. Most CLRNs have a lead for GI and Hepatology, and these individuals can advise on commercial studies and CLRN support funding. To find your Lead click here.
Recruiting to time and target - BRAG ratings
A national system of high level performance indicators has been developed to track which studies are broadly recruiting according to plan, and those which are falling behind with their recruitment and are at risk of not completing to time and target.The UK has traditionally had a poor record of recruiting to time and target compared to other countries, leading to a loss of confidence of the pharmaceutical industry, with the potential that this could lead to a progressive reduction in commercial studies. Academically-led studies which fail to meet their targets often result in requests for further funding in order to complete, or may fail to achieve a statistically significant result.This is not cost-effective and participation of patients in a study which is under powered is unethical.
Trial of the Month
This is a pragmatic trial to compare the clinical- and cost-effectiveness of infliximab and ciclosporin in the treatment of acute severe ulcerative colitis that fails to respond to intravenous steroids.
Update: March 2011
Thirty-six sites have now been visited and trained. Out of these sites 33 have been fully activated. 183 patients have been recruited to a cohort of patients admitted with acute severe colitis, and 29 of these have been recruited to the trial following failure to respond to steroids.
Training visits have been arranged for a further four sites have R&D approval. It is anticipated that they will be activated between mid February – mid March 2011. There are also 17 sites seeking R&D approval and a further 17 new sites are considering taking part.
With the number of active sites increasing we hope to see recruitment figures grow, but we are concerned by the slow rate of recruitment in activated sites to date. This is much lower than had been predicted.
We have recently issued all activated sites with a recruitment guide to ensure that all possible cases are being picked up including ways to identify patients. The guide also reiterates that CONSTRUCT is a pragmatic study with the ability for sites to follow their normal practice (including the flexibility to use clinical judgement and clinical decisions, to use clinical criteria to determine patients’ eligibility and to adapt treatment to patient).
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