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• W2133660198 abstract "Although randomized trials provide the most reliable evidence of a drug's safety and efficacy, there are situations where randomized trials are not possible or ethical. In this article we discuss when and how single-arm trials can be used to support full approval of oncology drugs. These include situations in which an unprecedented effect on tumor response is observed in a setting of high unmet medical need, clinical trial patients have been well characterized, enabling a target population to be clearly defined, experience exists in a sufficient number of patients to allow adequate assessment of the risk:benefit relationship, and a proper historical context can be provided for analysis. We also discuss how response rates might be considered predictive of long-term outcomes or clinically meaningful in and of themselves in certain contexts." @default.
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• W2133660198 date "2015-04-07" @default.
• W2133660198 modified "2023-10-03" @default.
• W2133660198 title "The role of nonrandomized trials in the evaluation of oncology drugs" @default.
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• W2133660198 doi "https://doi.org/10.1002/cpt.86" @default.
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