Evidence
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First, the assumptions underlying these methods deserve closer scrutiny. Positivity, in particular, is not merely a technical condition: when overlap between the trial and the observational sample is limited, generalization is possible only to a restricted population without extrapolation, and deterministic violations must be ruled out on substantive grounds.
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Integrative analysis of randomized clinical trials with real world evidence studies ↗
The transportability of the outcome mean function from the RCT sample to the RWE sample in Assumption 7 is testable, so potential tests for this assumption can be developed to verify this assumption. Assumption 3 states that all real-world patients have nonzero probabilities of participating the RCT…
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The transportability of the outcome mean function from the RCT sample to the RWE sample in Assumption 7 is testable, so potential tests for this assumption can be developed to verify this assumption. Assumption 3 states that all real-world patients have nonzero probabilities of participating the RCT. This assumption requires the absence of patient characteristics that prohibit participation to the RCT. This assumption holds for the CALGB 9633 trial by its protocol. When the positivity assumption is violated, there is limited overlap in the support of covariate in RCT and RWE samples, the generalization can only be made to a restricted population without extrapolation ( Yang and Ding, 2018a ) . In practice, health scientists should carefully examine the question at hand to eliminate deterministic violations of positivity.