Ensuring Ethical Postprogression Therapy for Patients in Randomized Trial Control Arms

Cliff ERS, Kesselheim AS, Feldman WB - Journal of Clinical Oncology

  • Regulation and Clinical Evidence

Summary:

Randomized oncology trials are ethically and scientifically compromised when patients in control arms are denied timely access to standard‑of‑care therapies after disease progression, particularly when investigational drugs already have known efficacy in later‑line settings. Ensuring post‑progression crossover is essential both to respect trial participants’ contributions and to produce valid overall‑survival evidence, and should be treated as a core requirement of ethical trial design rather than an optional feature.

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