The article Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project has been recently published in the British Journal of Clinical Pharmacology.
Fedele Bonifazi, president of Fondazione Gianni Benzi, co-authored this work as member of the Health Technology Assessment (HTA) expert group, set up within the conect4children (c4c) project.
This group supports the quality and efficiency of both the drug development and the price of and reimbursement processes.
The HTA group provides a concrete support for the development of clinical trials, considering the efficacy of the treatment, but also its value to the collective; it also contributes to the debate regarding the challenges that limit the current development of paediatric clinical trials.
The article aims at describing the most relevant elements of the drug development process in the paediatric field by focusing on the HTA.
Factors that influence market access for new paediatric medicines and patients' access to treatment as well as the methodological challenges in conducting HTA in the paediatric field are widely discussed.
In particular, authors point out how methodological obstacles, administrative procedures and compliance with legislation, as well as the correct balancing of the interests at stake, represent a complex system of actors and rules. Therefore, they conclude that one potential way to deal with this complexity is to exploit cooperation mechanisms.
In this framework, c4c aims to offer a more efficient process, from clinical trials to daily clinical practice, and to build a network of stakeholders involved in the priorities of the paediatric setting.
Discover more by reading the full article here!
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389.
The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.