Preclinical and clinical trials

King’s Technology Evaluation Centre (KiTEC) was established in 2011. Members of King’s UMS contribute expertise in study design, registers, databases, systematic review, meta-analysis and statistical modelling to the work of the Medical Technologies Evaluation Programme (MTEP), part of the National Institute for Health and Care Excellence (NICE). SeHCAT (tauroselcholic [75 selenium] acid) is a radiolabeled synthetic bile acid which can be used to confirm a clinical diagnosis of Bile Acid Malabsorption (BAM), a common cause of many diarrheal conditions.

NICE published Diagnostic Guidance (DG7) in 2012 on SeHCAT for the investigation of diarrhoea caused by BAM in people with Irritable Bowel Syndrome-Diarrhoea or Crohn’s disease without ileal resection. DG7 noted the lack of evidence on the cost-effectiveness of SeHCAT, and recommend further research. KiTEC was commissioned to evaluate SeHCAT, and in 2013/2014, led by King’s UMS members, conducted a nationwide service evaluation of SeHCAT use that would contribute to a future study which could directly address DG7.

Over 35 centres contributed routinely collected data on over 1,000 patients. Using the findings of this study, UMS members developed a study protocol that would address the research recommendations of DG7.

You can read more about the study results here, and the protocols was published here.