IMAP
Research type
Research Study
Full title
INTERNATIONAL STUDY ON MEDICINES ACCEPTABILITY IN PAEDIATRICS (Sub study in the hospitalized patients in Alder Hey, United Kingdom)
IRAS ID
258803
Contact name
Jennifer Duncan
Contact email
Sponsor organisation
Alder Hey Childrens NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The objective of this study is to increase the knowledge on factors affecting medicine acceptability in the paediatric population, using a standardized assessment tool: CAST - ClinSearch Acceptability Score Test®.
This research is important because the acceptability of medicines can affect a person’s willingness to take them. Poor compliance could potentially cause poor health outcomes as a result of treatment failure or complications. This is particularly important in the paediatric population. The European Medicines Agency, underlines the importance of acceptability and its critical effect on compliance. It also states that evaluation of acceptability should be an integral part of the pharmaceutical and clinical development of a medicine. However, at present there is no internationally agreed method to evaluate the acceptability of medicines.
A national study in France showed they were able to assess the acceptability of medicines in children. The model used (CAST) allowed positioning of any medicine on an ‘acceptability map’ allowing comparison between medicines and patient populations. In order to increase knowledge on medicines acceptability this study is looking at a wider population, with a sub study being conducted at Alder Hey Children’s Hospital.
Eligible paediatric patients will be approached by a member of the research team. An age appropriate information sheet will be provided. Once appropriate consent/assent is obtained the patient will be observed taking their prescribed medicine, which is part of their normal treatment. An online questionnaire will be completed by a member of the research team. The patient (if >12 years of age) or their parent can also complete the questionnaire if desired. A patient access code (identifier) will be provided for each patient, meaning the data held will be anonymous with no patient identifiable data. The results of the study could contribute to better and more appropriate formulations of medicines for the paediatric population.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0074
Date of REC Opinion
15 Mar 2019
REC opinion
Favourable Opinion