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01/24/2023
Oncology clinical trial design planning based on a multistate model that jointly models progression-free and overall survival endpoints
When planning an oncology clinical trial, the usual approach is to assum...
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08/13/2022
Applying the Estimand and Target Trial frameworks to external control analyses using observational data: a case study in the solid tumor setting
In causal inference, the correct formulation of the scientific question ...
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06/10/2022
Quantification of follow-up time in oncology clinical trials with a time-to-event endpoint: Asking the right questions
For the analysis of a time-to-event endpoint in a single-arm or randomiz...
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10/13/2020
Conditional Power and Friends: The Why and How of (Un)planned, Unblinded Sample Size Recalculations in Confirmatory Trials
Adapting the final sample size of a trial to the evidence accruing durin...
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10/01/2020
Estimands in Hematologic Oncology Trials
The estimand framework included in the addendum to the ICH E9 guideline ...
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08/18/2020
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) – estimation of adverse event risks
The SAVVY project aims to improve the analyses of adverse event (AE) dat...
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08/18/2020
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) – comparison of adverse event risks in randomized controlled trials
Analyses of adverse events (AEs) are an important aspect of benefit-risk...
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08/12/2020
Principal Stratum Strategy: Potential Role in Drug Development
A randomized trial allows estimation of the causal effect of an interven...
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06/28/2020
A review of Bayesian perspectives on sample size derivation for confirmatory trials
Sample size derivation is a crucial element of the planning phase of any...
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11/30/2019
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study
The assessment of safety is an important aspect of the evaluation of new...
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01/04/2019
Integrating Phase 2 into Phase 3 based on an Intermediate Endpoint While Accounting for a Cure Proportion
For a trial with primary endpoint overall survival for a molecule with c...
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10/25/2018
Joint modelling of progression-free and overall survival and computation of correlation measures
In this paper, we derive the joint distribution of progression-free and ...
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08/22/2018
A multistate model for early decision making in oncology
The development of oncology drugs progresses through multiple phases, wh...
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11/20/2017