Children have the right to know in advance which medicines they need and why. They should be allowed to express their own views and granted the right to participate in the decision-making process concerning their own health.
This is the assumption at the basis of development of the GAPP age-tailored information materials for clinical trials in children and young people that have been developed in a collaborative effort among pharmacologists, pediatricians, child psychologists and illustrators and already translated into seven languages: Albanian, Dutch, English, French, German, Greek and Italian.
In particular, the age-tailored information booklets and assent forms have been developed with a language and a wording appropriate to age, psychological and intellectual maturity, taking into account the cultural and linguistic differences. The informative documents are designed to inform the participant on the study’s objectives and procedures and to obtain his/her assent to participate in the study. Moreover, two animated videos, for children and adolescent respectively, have been developed with the aim to present in plain language general information on clinical trials.
A patient diary has been also developed to register specific daily data on the use of the IMPs, rescue and concomitant medication, pain scores and adverse effects when the patient is at home. It also contains instructions for the use of the IMP, troubleshooting and contact details of the study medical staff.
The information materials are available at the dedicated “Patients & Families” page of the GAPP Project.