The use of randomisation-based efficacy estimators in non-inferiority trials.

Background: In a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However, PP analysis relies on the often implausible assumption of no confounders. Randomisation-based efficacy estimators (RBEEs) allow for treatment non-adherence while maintaining a comparison of randomised groups.

Faecal calprotectin: a new marker for Crohn's disease?

Background: Gastroenterologists are often hampered by the lack of a reliable, non-invasive index of bowel inflammation when establishing a differential diagnosis for patients presenting with chronic diarrhoea. Investigations aim to distinguish between inflammatory bowel disease (IBD) (e.g.