{
  "abstract": "Introduction The ESSENCE trial is a phase-3, multicentre-placebo-controlled study evaluating once-weekly subcutaneous semaglutide in patients with biopsy-confirmed metabolic-dysfunction-associated-steatohepatitis (MASH). The trial consists of two parts, with the primary outcomes focussing on histological endpoints in part 1 and on clinical endpoints in part 2. Given the burden of repeated liver biopsies, extended duration, and placebo-controlled design, patient retention has been identified as a critical challenge, particularly in Part 2, where data integrity is essential. By sponsoring and managing trials internally, through a dedicated clinical operation and a clinical medical team, Novo Nordisk partners closely with sites to continuously refine study conduct. As part of our commitment to improving trial execution, we conducted a site-staff survey to better understand recruitment and retention barriers and identify opportunities for optimisation.Methods A structured survey was distributed to 60 UK-based site-staff, including investigators, research nurses, and study coordinators involved in patient recruitment and retention. The 21-question survey covered communication and support from Novo Nordisk, accessibility of study materials, and perceived barriers to patient retention. Responses were collected using single-select, multiple-choice, and Likert-scale formats. Barriers were rated on a 5-point scale, where 1 indicated ‘no barrier at all’ and 5 indicated a ‘significant barrier.’ Subgroup analysis explored role-based differences. Data were analysed to identify key challenges and improvement opportunities.Results Responses were received from staff at 70% of active UK sites (n=17), including 5 investigators, 8 research nurses, and 4 study coordinators. Most respondents reported timely, clear communication from Novo Nordisk. While 65% felt well-informed about study materials and 76% found them accessible, around one-third indicated a need for further guidance to integrate them into routine practice. Subgroup analysis showed investigators had more difficulty accessing resources than other roles. Key barriers to recruitment and retention included concerns about the placebo arm (3.4/5), study duration (3.2/5), liver biopsies (2.9/5), and fitting the study into patients’ routines (2.9/5). Staff suggested enhancing patient support and improving communication about participant contributions to mitigate these challenges.Discussion Findings reflect strong site engagement and highlight opportunities to improve the relevance and accessibility of study resources, particularly for investigators. Tailored education and enhanced patient support could reduce participation barriers. Limitations include the small sample size and variability in site responsiveness. Novo Nordisk recognises the importance of making trials less burdensome and more supportive for patients and staff. Additional insights will follow from the forthcoming patient survey.",
  "authors": [
    {
      "affiliations": [
        "Novo Nordisk, UK"
      ],
      "name": "Simone Magnisio"
    },
    {
      "affiliations": [
        "Novo Nordisk, UK"
      ],
      "name": "Lesley Houston"
    },
    {
      "affiliations": [
        "Novo Nordisk, UK"
      ],
      "name": "Akshay Kumar"
    },
    {
      "affiliations": [
        "Novo Nordisk, UK"
      ],
      "name": "Suraj Pathak"
    }
  ],
  "title": "P22 Perspectives of clinical trial site staff on recruitment and retention barriers at UK centres participating in the ESSENCE trial",
  "uid": "514ca1a4-5306-5fc9-a9f1-b82781a3493d"
}