{
  "abstract": "Background and Importance Paediatric clinical trials are essential for developing evidence-based treatments tailored to children’s needs. However, their implementation is often limited by ethical, logistical and communication challenges. Understanding the perspectives of healthcare providers (HCP) involved in such trials is critical to improving trial design, patient recruitment, and retention.Aim and Objectives This study aimed to explore the attitudes of HCP (physicians and hospital pharmacists) towards paediatric clinical trials and to identify the main barriers they encounter in practice.Material and Methods Semi-structured qualitative interviews were conducted with 10 HCPs affiliated with a university hospital in Plovdiv, Bulgaria. Data collection focused on perceived challenges, ethical concerns and recommendations for improvement. Responses were assessed using thematic analysis.Results HCP reported that parental distrust was the most frequent barrier to paediatric clinical trial participation, often driven by fears of children being treated as ‘test subjects.’ Informed consent was challenged by parental anxiety and the difficulty of presenting complex medical information in accessible language. HCP highlighted the value of involving adolescents in decision-making to improve engagement. Ethical concerns centred on safety, particularly regarding severe adverse events and long-term effects of investigational drugs. Logistical challenges included excessive documentation and frequent hospital visits, which increased the burden on families. Suggested improvements included simplified educational materials, reduced administrative tasks, and transparent communication, alongside broader public awareness campaigns to strengthen trust and participation.Conclusion and Relevance HCP recognise the value of paediatric clinical trials but face substantial challenges related to parental trust, ethical concerns, and trial logistics. Addressing these issues through simplified communication, family-centred trial designs, and transparent collaboration could foster greater participation and improve the overall quality of paediatric research. These insights may inform future strategies to optimise trial feasibility and patient engagement.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Medical University of Plovdiv, Department of Organisation and Economics of Pharmacy, Plovdiv, Bulgaria"
      ],
      "name": "H Stoynova"
    },
    {
      "affiliations": [
        "Medical University of Plovdiv, Department of Organisation and Economics of Pharmacy, Plovdiv, Bulgaria"
      ],
      "name": "R Staynova"
    },
    {
      "affiliations": [
        "Medical University of Plovdiv, Department of Organisation and Economics of Pharmacy, Plovdiv, Bulgaria"
      ],
      "name": "D Kafalova"
    }
  ],
  "title": "5PSQ-035 Challenges in conducting paediatric clinical trials: lessons from healthcare providers’ experiences",
  "uid": "14fcb87c-d9d3-5647-9028-4224d96a2ec3"
}