Donato Bonifazi to Present Research on Synthetic Control Arms
TEDDY Network is pleased to participate in the European Health Management Conference (EHMA) 2026, taking place from 10-12 June 2026 in Barcelona, Spain. Under the theme “Future-proofing Health Systems for a Changing World: From Strategy to Action,” the conference will bring together healthcare leaders, policymakers, researchers, and health managers from across Europe to discuss the future of health systems and healthcare innovation.
Donato Bonifazi, Chair of TEDDY Network, represented the organisation by presenting a scientific poster in the conference track “Policy and Regulations”, entitled “Use of Synthetic Control Arms in Clinical Trials as a Promising Approach for Generating Evidence.”
The research work on the use of Synthetic Control Arms in clinical trials as a promising approach for generating evidence was developed by TEDDY Network members, Giorgio Reggiardo (TEDDY Network), Viviana Giannuzzi (Gianni Benzi Pharmacological Research Foundation, FGB), Claudia Pansieri (Clinical Validation from Biopharmaceutical Findings, CVBF), Mariagrazia Felisi (Clinical Validation from Biopharmaceutical Findings, CVBF), Donato Bonifazi (TEDDY Network), and Adriana Ceci (Gianni Benzi Pharmacological Research Foundation, FGB).
The research was developed within the activities of the TEDDY Network Working Group on Paediatric Research Methodologies, coordinated by Giorgio Reggiardo. The Working Group promotes the development and evaluation of innovative methodological approaches aimed at improving the design, and assessment of paediatric clinical research, with a particular focus on generating high-quality evidence for children and young people.
Overview of the Presented Study on Synthetic Control Arms
Synthetic Control Arms (SCAs) are an innovative approach to clinical trial design that use real-world or historical data to replace or supplement traditional control arms. They are particularly relevant in rare diseases and paediatric research, where patient populations are limited and ethical concerns may arise.
The research findings presented at EHMA 2026 analysed completed single-arm studies registered in the EU Clinical Trials Register. Among more than 44,000 registered trials, only 14 studies (0.03%) were found to have incorporated a Synthetic Control Arm, and none involved paediatric patients.
TEDDY Network’s participation in EHMA 2026 reflects its ongoing commitment to advancing innovative methodologies, strengthening paediatric clinical research, and contributing to evidence-based healthcare policies across Europe.