{
  "abstract": "Backgrounds The incidence of paediatric inflammatory bowel disease (pIBD) is rising. There is an unmet need to understand disease causation and match disease phenotypes to efficacious drugs. Unfortunately, new drug trials in pIBD have lagged adults, as a consequence of which only two biologics are licensed for pIBD in a majority of countries. Some of the new generation biologics and oral small molecules are only available off-label on a case-by-case basis.Sheffield Children’s NHS Foundation Trust (SCH) has developed a growing portfolio of clinical research trials in commercial Clinical Trial Investigational Medicinal Product (CTIMP) trials in 2024. More than seven studies have opened or are in the later stages of set-up, leading the UK’s paediatric gastroenterology IBD-specific research portfolio. Trials range from oral to intravenous medications for both Crohn’s Disease and Ulcerative Colitis, sponsored by a range of pharmaceutical companies. SCH has accumulated many first patient recruitments in both the UK and Europe, whilst also maintaining its status as the lead paediatric IBD centre in the North of England.Aims Our aim is to perform a stakeholder analysis, involving the trust, research team, pharmaceutical company, patient and families, to understand the interplay of various factors, roadblocks and putative solutions in establishing an IBD research portfolio within SCH.Methodology A qualitative study design was utilised, whereby the study team members, principal investigator, and patients/families discussed the barriers and obstacles to initiation and management of an extensive portfolio of commercial IBD clinical trials within a specialist paediatric NHS trust.Future Implications It is hoped that other paediatric and adult services in the NHS, as well as healthcare services more globally, can exchange knowledge and experiences to improve the management of similar portfolios of complex commercial trials, to further enhance treatment and outcomes for children with this debilitating condition.References N/A",
  "authors": [
    {
      "affiliations": [
        "Sheffield Children’s Hospital"
      ],
      "name": "Aimee Corcoran"
    },
    {
      "affiliations": [
        "Sheffield Children’s Hospital"
      ],
      "name": "Akshay Kapoor"
    }
  ],
  "title": "OC103 Establishing a gastroenterology commercial research portfolio specialising in paediatric inflammatory bowel disease, at a UK specialist paediatric NHS foundation trust",
  "uid": "cbdc6986-e4a7-5064-a1ea-7719cea48390"
}