Alberto Servetto
Alberto Servetto/vjoncology.com

Alberto Servetto: Performance of Control Arms in Trials Leading to FDA Cancer Drug Approvals

Alberto Servetto, Assistant Professor of Oncology at University of Naples Federico II, shared a post on LinkedIn:

“Finally out in Journal of National Comprehensive Cancer Network® (NCCN®) the last paper from our team, titled “Performance of Control Arms in Trials Leading to FDA Cancer Drug Approvals”.

Key Findings:
In 24/72 (33.3%) trials that led to FDA cancer drug approvals between 2014 and 2023, control arm PFS underperformed, compared to assumed mPFS value of the study protocol.

These findings highlight the need to carefully evaluate the performance of control arms for a comprehensive assessment of the efficacy of new experimental treatments.

This work was led by two amazing residents, Angela Viggiano and Fabio Salomone, at School of Medical Oncology of University of Naples Federico II

Thanks to all collaborators for their precious support.
Luigi Liguori, Fabiana Napolitano, Filippo Vitale, Felice Pepe, Giuseppe Viscardi, Luigi Formisano, Roberto Bianco

This work was supported by AIRC – Foundation for Cancer Research NGO.”

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