Fragility of randomized trials supporting cancer drug approvals stratified by approval pathway and review designations

Autor: Michelle B. Nadler, Ariadna Tibau, Alexandra Desnoyers, Eitan Amir, Brooke E Wilson

Publikováno v: Cancer Medicine, Vol 10, Iss 16, Pp 5405-5414 (2021)
Cancer Medicine

Background It has been suggested that the results from fragile trials are less likely to translate into benefit in routine clinical practice. Methods We searched the Food and Drug Administration (FDA) archives to identify drug approvals for solid org

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::680358d1267743c6403e12774316a863
https://doaj.org/article/2af1bdd1e81e43c287847d8356afe589

Fragility of randomized trials supporting cancer drug approvals stratified by approval pathway and review designations.

Autor: Wilson BE; Princess Margaret Cancer Centre, Department of Medical Oncology, University of Toronto, Toronto, ON, Canada.; University of New South Wales, Kensington, NSW, Australia., Desnoyers A; Princess Margaret Cancer Centre, Department of Medical Oncology, University of Toronto, Toronto, ON, Canada., Nadler MB; Princess Margaret Cancer Centre, Department of Medical Oncology, University of Toronto, Toronto, ON, Canada., Tibau A; Oncology Department, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, and Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain., Amir E; Princess Margaret Cancer Centre, Department of Medical Oncology, University of Toronto, Toronto, ON, Canada.

Publikováno v: Cancer medicine [Cancer Med] 2021 Aug; Vol. 10 (16), pp. 5405-5414. Date of Electronic Publication: 2021 Jul 28.