Results for 'contextualization'
Browse oncology articles matching contextualization — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.
J. Mulder, S. Teerenstra, P. B. van Hennik, A. M. G. Pasmooij, V. Stoyanova-Beninska, E. E. Voest & A. de Boer
Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit
single-arm trials, anticancer medicinal products, EU, trial, SAT's, oncology, European Medicines Agency, clinical benefit, contextualization
Between 2012 and 2021, 18 anticancer medicinal products for solid tumors were approved in the EU based on 21 SATs (single-arm trials). Pivotal SAT-based applications often included additional information for contextualization, such as supportive studies and external evidence. Thresholds for…
Apr 11th • 14 mins read