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06/27/2023
On fixed and uncertain mixture prior weights
This paper focuses on the specification of the weights for the component...
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12/21/2022
Duration of and time to response in oncology clinical trials from the perspective of the estimand framework
Duration of response (DOR) and time to response (TTR) are typically eval...
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12/20/2021
The Predictive Individual Effect for Survival Data
The call for patient-focused drug development is loud and clear, as expr...
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10/01/2020
Estimands in Hematologic Oncology Trials
The estimand framework included in the addendum to the ICH E9 guideline ...
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08/12/2020
Principal Stratum Strategy: Potential Role in Drug Development
A randomized trial allows estimation of the causal effect of an interven...
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09/20/2019
Alternative Analysis Methods for Time to Event Endpoints under Non-proportional Hazards: A Comparative Analysis
The log-rank test is most powerful under proportional hazards (PH). In p...
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08/21/2019
Beyond p-values: a phase II dual-criterion design with statistical significance and clinical relevance
Background: Well-designed phase II trials must have acceptable error rat...
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08/20/2019
Bayesian leveraging of historical control data for a clinical trial with time-to-event endpoint
The recent 21st Century Cures Act propagates innovations to accelerate t...
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08/20/2019