Developing childcentered methods for medicine acceptability assessment

  • Research type

    Research Study

  • Full title

    Using participatory methods with children to develop child-centred measures for assessing the acceptability of medicine for children

  • IRAS ID

    244188

  • Contact name

    Bethany Gibson

  • Contact email

    gibsonb@edgehill.ac.uk

  • Sponsor organisation

    Edge Hill University

  • Clinicaltrials.gov Identifier

    FOHS 204, Edge Hill University- Faculty Research Ethics Committee (FREC) approval

  • Duration of Study in the UK

    1 years, 4 months, 1 days

  • Research summary

    Children are entitled to access age-appropriate and acceptable medicines. The increasing acknowledgement of the lack of formulations developed for the paediatric population has spurred a movement within the pharmaceutical and regulatory industries to adapt and develop medicines to be specifically formulated for children. This requires an understanding of what children deem acceptable in the context of medicine formulation, and the acknowledgement of the need for age-appropriate tools to test the acceptability of medicines.

    This study has two main aims. The first is to gain a better understanding of child acceptability of paediatric formulations. The second is to explore the ways in which children can be involved in the design and development of the tools that are created to assess the acceptability of paediatric pharmaceutical formulations.

    This two-phased study adopts a participatory approach and uses qualitative and quantitative methods to generate data with children aged 5-12 years old. Phase 1 focused on generating an understanding of children’s perceptions of the acceptability of medicines and on the initial co-design of acceptability tools and Phase 2 focuses on refining the tools to ensure children’s satisfaction with them.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    19/LO/0918

  • Date of REC Opinion

    25 Jun 2019

  • REC opinion

    Further Information Favourable Opinion