Becoming a Leader: Donato Bonifazi on ‘Managing Trials’

Becoming a Leader: Donato Bonifazi on ‘Managing Trials’

Dr Donato Bonifazi, in his role as iCAN Advisory Board Member, has participated in the International Children’s Advisory Network (iCAN), “Becoming a Leadershort videos series to talk about the challenges of conducting clinical trials for and with the paediatric population.  

According to Dr Bonifazi “we’ll not only need to adapt adults’ medicines to children, but we need to discover appropriate treatments for all paediatric diseases”.  

In his role as CVBF CEO, Dr Donato has been involved in the managing of some paediatric clinical trials all over Europe, including the DEEP – DEferiprone Evaluation in Paediatrics project, 6-year European Project (FP7) coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), comprising 23 recruiting centres in European and non-European countries, scientific partners from several European countries and a pharmaceutical group based in Canada, which involved 400 patients.  

The aim of DEEP is to provide data on deferiprone pharmacokinetics in younger children (DEEP-1), to evaluate the safety of deferiprone in the clinical setting through a long-term observational study (DEEP-3) and to generate new comparative efficacy/safety data to be used to grant a Marketing Authorisation (MA) of a new liquid formulation of the drug (DEEP-2), specifically developed for use in children affected with beta-thalassaemia major.  

For DEEP-2 trial, paediatric patients’ informative materials were developed and now KIDS Albania and KIDS Bari advisory groups are working to support the development of an age-tailored Lay Summary of the study for children. The informative materials ot the trial are available here.  

More information about the DEEP project, including the results of the clinical trials are available here 

You can access the video here 

January 13th, 2023|