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A bootstrapping method to optimize go/no-go decisions from single-arm, signal-finding studies in oncology.

CPT Pharmacometrics Syst Pharmacol · 2024 · PMC11330177 · PMID 38863167

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an observed trendno p-value reported
This method estimates the probability that observed differences were driven by the novel agent rather than random effects such as recruitment bias (e.g., random selection of PD‐1 responders) and also shows whether an observed trend occurs evenly across the participant population or only in a subset of the population.

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