2023
DOI: 10.1002/pst.2319
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Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development

Abstract: The addendum of the ICH E9 guideline on the statistical principles for clinical trials introduced the estimand framework. The framework is designed to strengthen the dialog between different stakeholders, to introduce greater clarity in the clinical trial objectives and to provide alignment between the estimand and statistical analysis. Estimand framework related publications thus far have mainly focused on randomized clinical trials. The intention of the Early Development Estimand Nexus (EDEN), a task force o… Show more

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Cited by 3 publications
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“…The model provides the conditional overall response rate (cORR) for every time point t after the index date. Another approach assessing the whole population is suggested by the EMA (2017) guidance 7 . It is defined as the time in response (Table 2, estimand 5): On patient level, DOR is defined as the time from onset of response to progression or death and is set to 0 for a patient with no response.…”
Section: Duration Of Response and Time To Responsementioning
confidence: 99%
“…The model provides the conditional overall response rate (cORR) for every time point t after the index date. Another approach assessing the whole population is suggested by the EMA (2017) guidance 7 . It is defined as the time in response (Table 2, estimand 5): On patient level, DOR is defined as the time from onset of response to progression or death and is set to 0 for a patient with no response.…”
Section: Duration Of Response and Time To Responsementioning
confidence: 99%