Ensuring Ethical Postprogression Therapy for Patients in Randomized Trial Control Arms

Abstract

@Eddie_Cliff et al explore the scientific & ethical reasons why patients randomized to the control arm of trials should 'crossover' to receive the investigational therapy if their disease progresses

Lessons from ADAURA: Can we improve on a positive trial?

“…23,24 In the face of low rates of crossover achieved in randomized trials of oncology agents, it can be argued that crossover should not merely be permitted but should be mandated when the treatment represents an evidence-based standard of care as subsequent therapy and the trial is effectively testing earlier administration of a therapy that would otherwise be routinely delivered to patients later. 24,25 Although there is a risk that the potential to demonstrate a significant improvement in OS is compromised by crossover, the relevant clinical question for a therapy that represents a standard of care as a later line therapy being tested as an earlier intervention should be whether changing the timing of a treatment from earlier to later confers an OS benefit. Including mandated crossover/subsequent therapy removes the confounding variable of access to that treatment.…”