According to the recent EMA recommendations any new developed pharma product should have proper clinical trials in children before its approval for the market. Clinical trials have been undertaken in this regard at the pediatric age. However the definition of the outcomes has been mirroring the adult trials outcomes without considering specificities of the pediatric age, including adolescents peculiarities. In addition, insights should be provided to facilitate adequate recruitment of the patients given the sensitivities at this age group.
It would be very timely for EAACI to deliver recommendations for clinical trials in allergic children that can serve as guidance to the health professionals community, to the policymakers and to the industry.
Planned outcome :
EAACI Position Paper on “Recommendations for Clinical trials in allergic children“ to be published in Allergy / PAI.
Last updated 09 February 2017