activity
20162023
most citedRecent advances in methodology for clinical trials in small populations: the InSPiRe project

50 citations · 66 across the 6 of their papers we have counts for

collaborators

7 papers

stat.ME2023

Methods for non-proportional hazards in clinical trials: A systematic review

Maximilian Bardo, Cynthia Huber, Norbert Benda +13

For the analysis of time-to-event data, frequently used methods such as the log-rank test or the Cox proportional hazards model are based on the proportional hazards assumption, wh…

stat.AP2020★ 6 cited

Subgroup identification in individual patient data meta-analysis using model-based recursive partitioning

Cynthia Huber, Norbert Benda, Tim Friede

Model-based recursive partitioning (MOB) can be used to identify subgroups with differing treatment effects. The detection rate of treatment-by-covariate interactions and the accur…

stat.AP2019

Blinded continuous information monitoring of recurrent event endpoints with time trends in clinical trials

Tobias Mütze, Susanna Salem, Norbert Benda +2

Blinded sample size re-estimation and information monitoring based on blinded data has been suggested to mitigate risks due to planning uncertainties regarding nuisance parameters.…

stat.AP2018★ 50 cited

Recent advances in methodology for clinical trials in small populations: the InSPiRe project

T. Friede, M. Posch, S. Zohar +19

Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical issues. This l…

stat.AP2018

Optimal Design in Hierarchical Models with application in Multi-center Trials

Maryna Prus, Norbert Benda, Rainer Schwabe

Hierarchical random effect models are used for different purposes in clinical research and other areas. In general, the main focus is on population parameters related to the expect…

stat.OT2018

On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies

Steffen Unkel, Marjan Amiri, Norbert Benda +14

The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading conclusions about a th…

q-bio.QM2016★ 10 cited

Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions

Steffen Unkel, Christian Röver, Nigel Stallard +4

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard design of clinical research to assess interventions. However, RCTs cannot always be applied for practical or e…