Phase III placebo-controlled oncology trials in the last decade: evolution, methodological foundations, and clinical impact - PubMed

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Placebo-controlled phase III trials remain central to oncology therapeutic development despite new treatments.
Placebo is used as a methodological tool to preserve blinding and minimize bias.
Key trials from 2015-2025 used placebo to validate benefits of immune checkpoint inhibitors and targeted agents.
In adjuvant settings, placebo provided ethical comparators for trials in lung cancer, melanoma, and breast cancer.
Maintenance strategies in ovarian, pancreatic, and AML cancers used placebo to reflect real-world surveillance.
Placebo-controlled trials in refractory disease helped identify new agents with survival benefits.
Placebo use reduces bias in time-to-event endpoints and ensures regulatory rigor.
These trials have facilitated major advances in oncology and will continue to be critical.

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