A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom - the CapaCiTY programme experience.

Background: The CapaCiTY programme includes three, multi-centre, randomised controlled trials aiming to develop an evidence based adult chronic constipation treatment pathway. The trials were conducted in the United Kingdom, National Health Service, aiming to recruit 808 participants from 26 March 2015 to 31 January 2019. Sites were selected based on their responses to site feasibility questionnaires (2014-2015), a common tool employed by sponsors to assess a site's recruitment potential and ability to undertake the trial protocol.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial.

Aim: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST).

Method: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention.

The future of clinical trials-is it virtual?

Introduction: Participant recruitment to clinical trials is often sub-optimal. Decentralized clinical trials have the potential to address challenges in traditional site-based clinical trial recruitment.

Sources Of Data: This review is based on recently published literature and the experience of running a large industry-sponsored interventional trial using both traditional and decentralized methods.

Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D).

Objective: Irritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.