ClinSearch’s paediatric medicine-acceptability tool CAST® obtains EMA Letter of Support
ClinSearch has just received a Letter of Support
from the European Medicines Agency (EMA) for its Acceptability Score Test for oral medicines in children under 12 years of age.
ClinSearch Acceptability Score Test (CAST®) was developed following the publication of the EMA Guideline
on pharmaceutical development of medicines for paediatric use.
This is the result of 9 years of a passionate R&D work, valuable partnerships with key researchers worldwide, and implementation in clinical trial and Real Word Evidence study settings.
The EMA highly appreciated the attempt to concretize and quantify the “catch-all” concept of acceptability and is looking for further experience of the CAST® score in clinical development plans.
This novel data-driven approach is based on thousands of observer-reported outcomes collected for various medicine intakes worldwide. Each evaluation combined several observed behaviours describing the many aspects of acceptability (e.g., required dose intake, preparation and administration time, patient reaction, use of methods to achieve administration…).
This acceptability reference framework aims to permit standardized acceptability evaluation, with any medicine assessed, using the CAST® questionnaire.
CAST® is used by research partners studying acceptability drivers and is the focus of ongoing clinical trials evaluating the acceptability of new medications in children.