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Maximizing treatment opportunities: assessing protocol waivers' impact on safety and outcome in the Drug Rediscovery Protocol.

J Maxime van Berge HenegouwenLaurien J ZeverijnBirgit S GeurtsLouisa R HoesHanneke van der WijngaartVincent van den NoortAlwin D R HuitemaFilip Yves Francine De VosKatrien GrünbergHaiko J BloemendalHenk M W VerheulEmile E VoestAndré 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.
Keyphrases
  • end stage renal disease
  • ejection fraction
  • newly diagnosed
  • chronic kidney disease
  • prognostic factors
  • machine learning
  • patient reported outcomes
  • big data
  • artificial intelligence
  • drug induced
  • adverse drug