Biomarker threshold adaptive designs for survival endpoints
نویسندگان
چکیده
منابع مشابه
Optimal designs for trials with discrete time survival endpoints
In studies on event occurrence the main question is whether and when a certain event occurs. Examples of events are smoking initiation, premature termination of therapy and recovery from some disease. The timing of such events cannot always be measured very precisely and coarse time intervals are used instead. At the end of each interval the occurrence of the event is measured, until and includ...
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Rationale for adaptive designs with multiple endpoints In clinical trials, the efficacy of a new treatment is usually assessed by a single primary endpoint [1,2]. Other important aspects concerning the new treatment, such as adverse events or quality of life, are taken into account by the definition of secondary endpoints. Usually, only the primary endpoint is analyzed confirmatorily with a sta...
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In adaptive design clinical trials, an endpoint at the final analysis that takes a long time to observe is not feasible to be used for making decisions at the interim analysis. For example, overall survival (OS) in oncology trials usually cannot be used to make interim decisions. However, biomarkers correlated to the final clinical endpoint can be used. Hence, considerable interest has been dra...
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BACKGROUND Many molecularly targeted anticancer agents entering the definitive stage of clinical development benefit only a subset of treated patients. This may lead to missing effective agents by the traditional broad-eligibility randomized trials due to the dilution of the overall treatment effect. We propose a statistically rigorous biomarker-adaptive threshold phase III design for settings ...
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ژورنال
عنوان ژورنال: Journal of Biopharmaceutical Statistics
سال: 2018
ISSN: 1054-3406,1520-5711
DOI: 10.1080/10543406.2018.1434191