Clinical Trials Update #4 March 2011

Clinical trial recruitment to GI and hepatology trials across the UK has shown further promising increases. There has also been a significant increase in participating centres for multi-centre studies, and continuing progress in BRAG status (see bottom of article). Nationally the target of doubling recruitment to high quality trials has already been met, 18 months ahead of schedule. The only disappointments are the slow rate of expansion of the GI portfolio, and the relative paucity of commercial studies coming through.

Key Messages

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).

If you would like details please contact us on This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Predicting 5-Aminosalicylate Nephrotoxicity in Patients with IBD (New Trial)

This is the first of a series of genetic studies, lead by the UK IBD Genetics consortium, investigating rare side effects to drugs used in patients with IBD. Our aim is to recruit 200 UK patients over the next 2 years. We anticipate that each hospital might be looking after 2-3 patients who meet the inclusion criteria.  Participation involves a blood test for DNA extraction, and completion of a case report form, patient questionnaire and consent form.

Nephrotoxicity is defined by a series of major and minor criteria which allow us to rank how certain we are that the 5-ASA is responsible. Any patient that meets the major criteria might be eligible: Current age > 18 years; normal Creatinine or eGFR at baseline; ≥50% rise in serum creatinine (with corresponding fall in eGFR, anytime after introduction of 5-ASA; expert renal opinion implicates 5-ASA

If would like to get involved, either as a research site or patient identification (PIC) site then please contact:

Tracey Hill
Trial Co-ordinator
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Tel: 07900 161244

Tariq Ahmad
Chief Investigator
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