87 citations · 557 across the 33 of their papers we have counts for
11 papers · 1 filter
Clinical trials with interim analyses: Standardizing Terminology to increase clarity
Elina Asikanius, Benjamin Hofner, Lisa V. Hampson +5
Interim analyses for group-sequential decision making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. St…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and a roadmap for the future of safety analyses in clinical trials
Kaspar Rufibach, Jan Beyersmann, Tim Friede +2
The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times…
Oncology clinical trial design planning based on a multistate model that jointly models progression-free and overall survival endpoints
Alexandra Erdmann, Jan Beyersmann, Kaspar Rufibach
When planning an oncology clinical trial, the usual approach is to assume proportional hazards and even an exponential distribution for time-to-event endpoints. Often, besides the…
Conditional Power and Friends: The Why and How of (Un)planned, Unblinded Sample Size Recalculations in Confirmatory Trials
Kevin Kunzmann, Michael J. Grayling, Kim M. Lee +3
Adapting the final sample size of a trial to the evidence accruing during the trial is a natural way to address planning uncertainty. Designs with adaptive sample size need to acco…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) -- estimation of adverse event risks
Regina Stegherr, Claudia Schmoor, Jan Beyersmann +12
The SAVVY project aims to improve the analyses of adverse event (AE) data in clinical trials through the use of survival techniques appropriately dealing with varying follow-up tim…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) -- comparison of adverse event risks in randomized controlled trials
Kaspar Rufibach, Regina Stegherr, Claudia Schmoor +12
Analyses of adverse events (AEs) are an important aspect of the evaluation of experimental therapies. The SAVVY (Survival analysis for AdVerse events with Varying follow-up times)…
Principal Stratum Strategy: Potential Role in Drug Development
Björn Bornkamp, Kaspar Rufibach, Jianchang Lin +6
A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristi…
A review of Bayesian perspectives on sample size derivation for confirmatory trials
Kevin Kunzmann, Michael J. Grayling, Kim May Lee +3
Sample size derivation is a crucial element of the planning phase of any confirmatory trial. A sample size is typically derived based on constraints on the maximal acceptable type…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study
Regina Stegherr, Jan Beyersmann, Valentine Jehl +4
The assessment of safety is an important aspect of the evaluation of new therapies in clinical trials, with analyses of adverse events being an essential part of this. Standard met…
Integrating Phase 2 into Phase 3 based on an Intermediate Endpoint While Accounting for a Cure Proportion -- with an Application to the Design of a Clinical Trial in Acute Myeloid Leukemia
Kaspar Rufibach, Dominik Heinzmann, Annabelle Monnet
For a trial with primary endpoint overall survival for a molecule with curative potential, statistical methods that rely on the proportional hazards assumption may underestimate th…
A multistate model for early decision making in oncology
Ulrich Beyer, David Dejardin, Matthias Meller +2
The development of oncology drugs progresses through multiple phases, where after each phase a decision is made about whether to move a molecule forward. Early phase efficacy decis…