A critique of the fragility index

• Author(s): Machado, Tiago ; Duarte, Gonçalo Silva ; Gonçalves, Nilza C. ; Ferreira, Joaquim J. ; Costa, João
• Date: 2019
• Persistent ID: http://hdl.handle.net/10451/39924
• Origin: Repositório da Universidade de Lisboa
• Document Type: Journal article
• Language: English
• Contributor(s): Repositório da Universidade de Lisboa

Description

Copyright © 2019 Elsevier B.V. or its licensors or contributors.

In The Lancet Oncology , Joseph Del Paggio and Ian Tannock report on a retrospective analysis of the fragility indices of phase 3 trials used by the US Food and Drug Administration (FDA) to approve anticancer drugs. 1 The authors conclude that “many phase 3 randomised controlled trials supporting FDA-approved anticancer drugs have a low fragility index, challenging confidence for concluding their superiority over control treatments.” Although this interpretation is interesting, we would like to draw attention to several points.