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Adjustment for exploratory cut-off selection in randomized clinical trials with survival endpoint
by Götte, Heiko (Author)
, Kirchner, Marietta (Author)
, Kieser, Meinhard (Author)
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Biometrical journal, 62 (2020), 3, Seite 627-642
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Optimal sample size allocation and go/no-go decision rules for phase II/III programs where several phase III trials are performed
by Erdmann, Stella (Author)
, Kieser, Meinhard (Author)
, Kirchner, Marietta (Author)
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Biometrical journal, 61 (2019), 2, Seite 357-378
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Optimal planning of phase II/III programs for clinical trials with multiple endpoints
by Kieser, Meinhard (Author)
, Kirchner, Marietta (Author)
, Dölger, Eva (Author)
, Götte, Heiko (Author)
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Pharmaceutical statistics, 17 (2018), 5, Seite 437-457
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Probability of success for phase III after exploratory biomarker analysis in phase II
by Götte, Heiko (Author)
, Kirchner, Marietta (Author)
, Sailer, Martin Oliver (Author)
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Pharmaceutical statistics, 16 (2017), 3, Seite 178-191
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Simulation-based adjustment after exploratory biomarker subgroup selection in phase II
by Götte, Heiko (Author)
, Kirchner, Marietta (Author)
, Kieser, Meinhard (Author)
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Statistics in medicine, 36 (2017), 15, Seite 2378-2390
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Utility-based optimization of phase II/III programs
by Kirchner, Marietta (Author)
, Kieser, Meinhard (Author)
, Götte, Heiko (Author)
, Schüler, Armin (Author)
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Statistics in medicine, 35 (2016), 2, Seite 305-316
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Sample size planning for phase II trials based on success probabilities for phase III
by Götte, Heiko (Author)
, Schüler, Armin (Author)
, Kirchner, Marietta (Author)
, Kieser, Meinhard (Author)
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Pharmaceutical statistics, 14 (2015), 6, Seite 515-524
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Klinikum der Universität Heidelberg
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Institut für Med. Biometrie und Informatik (bis April 2021)
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Kirchner, Marietta
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Götte, Heiko
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Kieser, Meinhard
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Schüler, Armin
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Dölger, Eva
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Erdmann, Stella
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Sailer, Martin Oliver
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probability of success
drug development program
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sample size
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optimization
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phase II/III
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ABC
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approximate Bayesian computation
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bias adjustment
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cut-off selection
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drug development
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drug development programme
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expected utility
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mixed exponential distribution
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multiple endpoints
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phase II trials
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posterior approximation
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program-wise planning
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selection bias
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subgroup analysis
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subgroup selection
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time to event
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time-to-event analysis
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