Search Results - "Rosenkranz, Gerd"

Replicability of studies following a dual‐criterion design by Rosenkranz, Gerd K.

“…Replicability of results is regarded as the corner stone of science. Recent research seems to raise doubts about whether this requirement is generally…”
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Exploratory subgroup analysis in clinical trials by model selection by Rosenkranz, Gerd K.

“…The interest in individualized medicines and upcoming or renewed regulatory requests to assess treatment effects in subgroups of confirmatory trials requires…”
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Subgroup identification in clinical trials via the predicted individual treatment effect by Ballarini, Nicolás M, Rosenkranz, Gerd K, Jaki, Thomas, König, Franz, Posch, Martin

“…Identifying subgroups of treatment responders through the different phases of clinical trials has the potential to increase success in drug development. Recent…”
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Bootstrap corrections of treatment effect estimates following selection by Rosenkranz, Gerd K.

“…Bias of treatment effect estimators can occur when the maximum effect of several treatments is to be determined or the effect of the selected treatment or…”
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Analysis of cross-over studies with missing data by Rosenkranz, Gerd K

“…This paper addresses some aspects of the analysis of cross-over trials with missing or incomplete data. A literature review on the topic reveals that many…”
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Empirical Bayes estimators in hierarchical models with mixture priors by Rosenkranz, Gerd K.

“…We consider subgroup analyses within the framework of hierarchical modeling and empirical Bayes (EB) methodology for general priors, thereby generalizing the…”
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Remarks on designs enriching for placebo non-responders by Rosenkranz, Gerd K

“…Background: High response under placebo constitutes a concern in clinical studies, particularly in psychiatry. Discontinuation of placebo responders identified…”
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The impact of randomization on the analysis of clinical trials by Rosenkranz, Gerd K.

“…The design of a comparative clinical trial involves a method of allocating treatments to patients. Usually, this assignment is performed to achieve several…”
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Mavoglurant in Fragile X Syndrome: Results of two open-label, extension trials in adults and adolescents by Hagerman, Randi, Jacquemont, Sebastien, Berry-Kravis, Elizabeth, Des Portes, Vincent, Stanfield, Andrew, Koumaras, Barbara, Rosenkranz, Gerd, Murgia, Alessandra, Wolf, Christian, Apostol, George, von Raison, Florian

“…Fragile X syndrome (FXS) is the most common monogenic cause of inherited intellectual and developmental disabilities. Mavoglurant, a selective metabotropic…”
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A note on the Hodges-Lehmann estimator by Rosenkranz, Gerd K.

“…The Hodges‐Lehmann estimator was originally developed as a non‐parametric estimator of a shift parameter. As it is widely used in statistical applications, the…”
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Applicability and added value of novel methods to improve drug development in rare diseases by Mitroiu, Marian, Rengerink, Katrien Oude, Pontes, Caridad, Sancho, Aranzazu, Vives, Roser, Pesiou, Stella, Fontanet, Juan Manuel, Torres, Ferran, Nikolakopoulos, Stavros, Pateras, Konstantinos, Rosenkranz, Gerd, Posch, Martin, Urach, Susanne, Ristl, Robin, Koch, Armin, Loukia, Spineli, van der Lee, Johanna H, Roes, Kit C B

“…The ASTERIX project developed a number of novel methods suited to study small populations. The objective of this exercise was to evaluate the applicability and…”
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subtee : An R Package for Subgroup Treatment Effect Estimation in Clinical Trials by Ballarini, Nicolas M., Thomas, Marius, Rosenkranz, Gerd K., Bornkamp, Björn

“…The investigation of subgroups is an integral part of randomized clinical trials. Exploration of treatment effect heterogeneity is typically performed by…”
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Analysis Sets and Inference in Clinical Trials by Rosenkranz, Gerd K.

“…The debate about what constitutes a valid analysis of clinical trial data is longstanding. While the intention-to-treat (ITT) principle seems to be widely…”
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Modeling laboratory data from clinical trials by Rosenkranz, Gerd K.

“…Abnormal laboratory data from clinical trials are considered precursors of potential organ dysfunction. Routine analysis of these data focusses primarily on…”
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An Approach to Integrated Safety Analyses from Clinical Studies by Rosenkranz, Gerd K.

“…The analysis of safety data of clinical studies poses specific problems that are related to a multiplicity of usually not explicitly specified hypotheses…”
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Another view on the analysis of cardiovascular morbidity/mortality trials by Rosenkranz, Gerd K.

“…In many morbidity/mortality studies, composite endpoints are considered. Although the primary interest is to demonstrate that an invention delays death, the…”
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Joint Modeling of Outcome, Observation Time, and Missingness by Kenward, Michael G., Rosenkranz, Gerd K.

“…A modeling framework is described for the specific setting of clinical trials in which there is only a single post-randomization response measurement, which…”
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Analysis of Adverse Events in the Presence of Discontinuations by Rosenkranz, Gerd

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Estimands—new statistical principle or the emperor's new clothes? by Rosenkranz, Gerd

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Is it possible to claim efficacy if one of two trials is significant while the other just shows a trend? by ROSENKRANZ, Gerd

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