Maximizing Treatment Opportunities: Assessing Protocol Waivers' Impact on Safety and Outcome in the Drug Rediscovery Protocol.

J Maxime van Berge Henegouwen Laurien J Zeverijn Birgit S Geurts Louisa R Hoes Hanneke van der Wijngaart Vincent van den Noort Alwin D R Huitema Filip Yves Francine De Vos Katrien Grünberg Haiko J Bloemendal Henk M W Verheul Emile E Voest André B P van Kuilenburg

Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2024)

Safety and clinical benefit were preserved in patients for whom a waiver was granted. These data support a more personalized approach in assessing eligibility criteria, especially in trials with widely used and approved drugs accruing patients without other treatment options. See related commentary by Waqar and Govindan, p. 3655.

Keyphrases

end stage renal disease
ejection fraction
newly diagnosed
chronic kidney disease
randomized controlled trial
peritoneal dialysis
prognostic factors
emergency department
patient reported outcomes
big data
drug induced
combination therapy
replacement therapy