Medicine acceptability in children
Research type
Research Study
Full title
International study on medicines acceptability in the paediatric patient population
IRAS ID
259181
Contact name
Elisa Alessandrini
Contact email
Sponsor organisation
ClinSearch
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Patient acceptability is defined by the European Medicines Agency as the ability and willingness to take a medicinal product as intended. The assessment of patient acceptability is crucial for the success of medicinal treatments, particularly in children. Poorly acceptable medicines are likely to cause non-adherence or medication errors that can ultimately result in safety issues to the patient. This study aims to increase the knowledge of the factors affecting medicine acceptability in paediatric patients aged 18 years or less. The researcher will observe participants (children who are taking the medicines and their carers who are helping/giving them), in the presence of hospital personnel during the patients’ hospital stay. The researcher will then answer a standardised online questionnaire collecting information related to the prescribed treatment(s), the patients’ ability to take the medicine, any visual reaction to the medicine (e.g. facial expressions), the time required to take the medication, the methods used to administer the medication, and the feedback from the person administering the medicine. No personal or sensitive data will be collected. The minimum number of participants required for the study is 30; however because acceptability may vary by age range of children and due to the wide range of products available, we will plan to recruit a higher number. An acceptability map of the medicinal products assessed will be produced using statistical methods.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0111
Date of REC Opinion
21 May 2020
REC opinion
Further Information Favourable Opinion