87 citations · 557 across the 33 of their papers we have counts for
7 papers · 1 filter
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…
Estimands in Hematologic Oncology Trials
Steven Sun, Hans-Jochen Weber, Emily Butler +2
The estimand framework included in the addendum to the ICH E9 guideline facilitates discussions to ensure alignment between the key question of interest, the analysis, and interpre…
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…
Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework
Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu +10
COVID-19 outbreak has rapidly evolved into a global pandemic. The impact of COVID-19 on patient journeys in oncology represents a new risk to interpretation of trial results and it…