René Schmidt
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Confirmatory Adaptive Hypothesis Tests in Markovian Illness-Death Models Open
Classic adaptive designs for time-to-event trials are based on the log-rank statistic and its increments. Thereby, only information from the time-to-event endpoint on which the selected log-rank statistic is based may be used for data-depe…
View article: Confirmatory Adaptive Designs for Clinical Trials With Multiple Time‐to‐Event Outcomes in Multi‐state Markov Models
Confirmatory Adaptive Designs for Clinical Trials With Multiple Time‐to‐Event Outcomes in Multi‐state Markov Models Open
The analysis of multiple time‐to‐event outcomes in a randomized controlled clinical trial can be accomplished with existing methods. However, depending on the characteristics of the disease under investigation and the circumstances in whic…
View article: Two-sample survival tests based on control arm summary statistics
Two-sample survival tests based on control arm summary statistics Open
The one-sample log-rank test is the preferred method for analysing the outcome of single-arm survival trials. It compares the survival distribution of patients with a prefixed reference survival curve that usually represents the expected o…
Adaption of neurosurgical resection patterns for pediatric low‐grade glioma spanning two decades—Report from the German <span>LGG</span>‐studies 1996–2018 Open
Introduction Neurosurgery is considered the mainstay of treatment for pediatric low‐grade glioma (LGG); the extent of resection determines subsequent stratification in current treatment protocols. Yet, surgical radicality must be balanced …
View article: LOGGIC/FIREFLY-2: a phase 3, randomized trial of tovorafenib vs. chemotherapy in pediatric and young adult patients with newly diagnosed low-grade glioma harboring an activating RAF alteration
LOGGIC/FIREFLY-2: a phase 3, randomized trial of tovorafenib vs. chemotherapy in pediatric and young adult patients with newly diagnosed low-grade glioma harboring an activating RAF alteration Open
Background Pediatric low-grade glioma (pLGG) is essentially a single pathway disease, with most tumors driven by genomic alterations affecting the mitogen-activated protein kinase/ERK (MAPK) pathway, predominantly KIAA1549::BRAF fusions an…
Confirmatory adaptive group sequential designs for clinical trials with multiple time-to-event outcomes in Markov models Open
The analysis of multiple time-to-event outcomes in a randomised controlled clinical trial can be accomplished with exisiting methods. However, depending on the characteristics of the disease under investigation and the circumstances in whi…
View article: Supplementary Figure 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Figure 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Figure 1. Highlights the EFS and OS for the cohort of neuroblastoma patients with MYCN-amplified disease (n=114, Fig 1a) and for th subcohort of patients >18 months of age with stage 4, MYCN non-amplified disease (n=102, fig.…
View article: Supplementary Figure 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Figure 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Figure 1. Highlights the EFS and OS for the cohort of neuroblastoma patients with MYCN-amplified disease (n=114, Fig 1a) and for th subcohort of patients >18 months of age with stage 4, MYCN non-amplified disease (n=102, fig.…
View article: Supplementary Table 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 2. External performance validation of the top five classifiers. This supplementary table comprises the external performance metrics of the top five classifiers. Indicated are the values for classification accuracy, sens…
View article: Supplementary Table 4 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 4 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 4. Transcripts that contribute to the SVM_th10 classifier. This supplementary table highlights the transcripts that constitute the SVM_th10 classifier. Indicated for each feature are the Oligo-ID, the Gene symbols, the …
View article: Supplementary Table 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 1. Clinical co-variates for the 709 patients who participated in the study. This supplementary table comprises detailed information on clinical co-variates for all 709 neuroblastoma patients who participated in the stud…
View article: Supplementary Table 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 1. Clinical co-variates for the 709 patients who participated in the study. This supplementary table comprises detailed information on clinical co-variates for all 709 neuroblastoma patients who participated in the stud…
View article: Supplementary Data 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Data 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Data 2. This supplementary data comprises the r-algorithm scripts required to perform the both model selection and validation as described in the step-by-step protocol
View article: Supplementary Data 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Data 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Data 1. This supplementary data comprises a step-by-step description on how our gene-expression based classification models were generated and validated
View article: Supplementary Table 3 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 3 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 3. This table summarizes the results of the Kaplan-Meier estimates for both EFS and OS of clinically relevant subgroups of neuroblastoma patients according to classification by the four remaining classifiers SVM_th22, S…
View article: Legends to Supplementaries from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Legends to Supplementaries from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Legends to Supplementaries. This documents comprises the legends to the supplementary figures and tables
View article: Supplementary Table 4 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 4 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 4. Transcripts that contribute to the SVM_th10 classifier. This supplementary table highlights the transcripts that constitute the SVM_th10 classifier. Indicated for each feature are the Oligo-ID, the Gene symbols, the …
View article: Legends to Supplementaries from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Legends to Supplementaries from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Legends to Supplementaries. This documents comprises the legends to the supplementary figures and tables
View article: Supplementary Table 3 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 3 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 3. This table summarizes the results of the Kaplan-Meier estimates for both EFS and OS of clinically relevant subgroups of neuroblastoma patients according to classification by the four remaining classifiers SVM_th22, S…
View article: Data from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Data from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Purpose: To optimize neuroblastoma treatment stratification, we aimed at developing a novel risk estimation system by integrating gene expression–based classification and established prognostic markers.Experimental Design: Gene expression …
View article: Supplementary Table 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Table 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Table 2. External performance validation of the top five classifiers. This supplementary table comprises the external performance metrics of the top five classifiers. Indicated are the values for classification accuracy, sens…
View article: Supplementary Data 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Data 1 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Data 1. This supplementary data comprises a step-by-step description on how our gene-expression based classification models were generated and validated
View article: Supplementary Data 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Supplementary Data 2 from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Supplementary Data 2. This supplementary data comprises the r-algorithm scripts required to perform the both model selection and validation as described in the step-by-step protocol
View article: Data from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers
Data from Revised Risk Estimation and Treatment Stratification of Low- and Intermediate-Risk Neuroblastoma Patients by Integrating Clinical and Molecular Prognostic Markers Open
Purpose: To optimize neuroblastoma treatment stratification, we aimed at developing a novel risk estimation system by integrating gene expression–based classification and established prognostic markers.Experimental Design: Gene expression …
View article: CTNI-30. LOGGIC/FIREFLY-2: A PHASE 3, RANDOMIZED TRIAL OF TOVORAFENIB VS. CHEMOTHERAPY IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED LOW-GRADE GLIOMA HARBORING AN ACTIVATING RAF ALTERATION
CTNI-30. LOGGIC/FIREFLY-2: A PHASE 3, RANDOMIZED TRIAL OF TOVORAFENIB VS. CHEMOTHERAPY IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED LOW-GRADE GLIOMA HARBORING AN ACTIVATING RAF ALTERATION Open
BACKGROUND Genomic alterations and dysregulation of RAF are the main oncogenic driver in almost all pediatric low-grade gliomas (pLGGs). About 50%‒60% of pLGGs harbor KIAA1549-BRAF fusion and 5%‒15% BRAF V600E mutation. No targeted therapy…
Reference curve sampling variability in one–sample log–rank tests Open
The one–sample log–rank test is the method of choice for single–arm Phase II trials with time–to–event endpoint. It allows to compare the survival of patients to a reference survival curve that typically represents the expected survival un…
INSP-04. Confirmatory adaptive designs for survival trials with several time-to-event endpoints Open
Confirmatory adaptive designs comprise a range of statistical methods that allow to modify the sample size of an ongoing trial in a data-dependent way without compromising control of the type I error rate. For short-term endpoints (e.g., 3…
On Variance Estimation for the One-Sample Log-Rank Test Open
Time-to-event endpoints show an increasing popularity in phase II cancer trials. The standard statistical tool for such one-armed survival trials is the one-sample log-rank test. Its distributional properties are commonly derived in the la…
On Variance Estimation for the One-Sample Log-Rank Test Open
The comparison of a time-to-event endpoint between a prospective study sample and a defined reference population is made with the one-sample log-rank test. This test is typically applied in epidemiologic studies as well as in specific phas…
Adaptive group sequential survival comparisons based on log-rank and pointwise test statistics Open
Whereas the theory of confirmatory adaptive designs is well understood for uncensored data, implementation of adaptive designs in the context of survival trials remains challenging. Commonly used adaptive survival tests are based on the in…