Paediatric trials have a default level of complexity, that is depending on regulatory, methodological, ethical and administrative issues, especially when they are registrative and international as DEEP-2 is.
DEEP-2 is, in fact, a multi-national and multi-center clinical trial involving not only a paediatric multi-ethnic population with different cultures, laws and children of different ages but also a rare and disperse population with different Rare Congenital Anaemia which has faced (and is still facing) several challenges in many countries, especially in the Mediterranean area.
We have discussed the Tunisian situation in performing a paediatric clinical study with Prof. Mohamed Bejaoui, the Principal Investigator at the Centre National de Greffe de Moelle Osseuse in Tunis.
“The Tunisian regulation allows to perform clinical trials in children since 2014, while prior to this date a special permission from the Ministry of Health had to be required before starting the trial. Today the clinical trials in children pose no administrative, regulatory or ethical problems and this is an important result that will pave the way towards a new era for clinical research in Tunisia, especially in paediatrics”.
Prof. Bejaoui stressed the importance of participating in an international research network as DEEP, because it allows the sharing of high-quality and effective knowledge with highly experienced research teams and to learn more about best practices of clinical trials. The international cooperation in clinical research is also a way to encourage interdisciplinary participation in developing solutions through high-impact and mission-driven collaborations.
Considering that clinical trials cannot be conducted on patients without prior obtaining their written consent and the situation could be slightly more challenging when involving paediatric patients, whom consent is deputized the parents/legal guardians, we asked Prof. Bejaoui how the site manages the problem of consent.
“Informed consent is necessary before the start of the trial. At our Center, a long interview is conducted by the principal investigator and at least one of his associates with each family. Children are followed during all the clinical trial. We talk to the child about the disease, we explain the different treatments available for the disease, the drug under study, the conduct of the trial, monitoring practices, potential treatment complications and so on. The child assent is fully voluntary and without any constraints whatsoever and when we are sure that the child and his/her parents have understood what this trial is for and how it works, we do generally receive any opposition to the sign of the informed consent, thus allowing the recruitment of a large number of patients. In this context – he further explained – we would like to step forward at our center and take part in the recently launched QuBo (Quality evaluation of the informative booklets for patients involved in the DEEP-2 trial) study, aimed to Quality evaluation of the informative booklets for patients involved in the DEEP-2 trial aimed to test the efficacy of the informative materials developed within the DEEP2 clinical trial in order to evaluate the level of readability, clarity and intelligibility for each age group”.