Conference Agenda

Tim P. Morris, Ian R. White

Tim P. Morris, Ian R. White

Tim P. Morris, Ian R. White

Tim P. Morris, Ian R. White

The Power of Three. A Framework to Guide Analysis of Covariance in Randomised Clinical Trials.

Stephen John Senn, Franz Koenig, Martin Posch

Stirring the pot: combining influence functions and Wald type tests for more powerful closed testing procedures

Christian Bressen Pipper, Klaus Holst

Analyzing multi-center randomized trials with covariate adjustment while accounting for clustering

Muluneh Alene Addis, Kelly Van Lancker, Stijn Vansteelandt

Increasing efficiency of composite endpoint trials: Novel Bayesian latent variable framework with application to late-stage trials

Paul Newcombe, Jasna Cotic, Aris Perperoglou, James Wason, Dave Lunn

Ordinal Outcome Analysis in Neurological Trials: Current Practices and the Proportional Odds Debate

Yongxi Long, Bart Jacobs, Ewout Steyerberg, Erik van Zwet

What is the estimand for the proportional odds model?

Ian R White, Brennan C Kahan

On the use of the net treatment benefit as a treatment-effect measure in randomized clinical trials

Tomasz Burzykowski, Vaiva Deltuvaite-Thomas

Challenges and opportunities in defining new estimands for longitudinal outcomes truncated by death

Juliette ORTHOLAND, Marie-Abèle BIND

What estimands can and should be used when interventions may be given more than once?

Joanna Anetta Hindley, Michelle Clements, James Carpenter, Brennan Kahan

Current practice around the use of estimands in cluster randomised trials, and the impact of informative cluster size on inferences

Dongquan Bi, Andrew Copas, Brennan Kahan

The role of post intercurrent event data in the estimation of hypothetical estimands in clinical trials

Jonathan Bartlett

Bringing together estimands, causal inference and pharmacometric modeling and simulation

Christian Bartels, Manuela Zimmermann, Siyan Xu, Neva Coello

Nonparanormal Adjusted Marginal Inference

Susanne Dandl, Torsten Hothorn

Estimation of effects with treatment policy handling for binary outcomes using multiple imputation

Sunita Rehal

Can Treatment Effect Testing in Trials with Intercurrent Events Be Nearly Assumption-Free?

Georgi Baklicharov, Kelly Van Lancker, Stijn Vansteelandt

Location-Scale Latent Process Model for Repeated Ordinal Patient Reported Outcomes

Agnieszka Król, Robert Palmér, Jacob Leander, Cécile Proust-Lima, Alexandra Jauhiainen

Causal approaches for the design and long-term treatment effect estimations of hybrid randomized clinical trials with longitudinal outcomes

Xiner Zhou, Herbert Pang, Christiana Drake, Hans Ulrich Burger, Jiawen Zhu

Prediction powered inference for trials with survival outcomes

Maylis Tran, Pierre-Emmanuel Poulet, Bruno Jedynak, Sophie Tezenas du Montcel

Repeated measurements modelling of titration effects in multi-arm clinical trials

Emma Ove Dahl, Philip Hougaard

Reevaluating Recurrent Events in Heart Failure Trials: Patterns, Prognostic Implications, and Analytical Improvements

Audinga-Dea Hazewinkel, John Gregson, Stuart J Pocock, John McMurray, Scott D Solomon, Brian Claggett, Milton Packer, Stefan D Anker, João P Ferreira, Kieran Docherty, Alasdair Henderson, Pardeep Jhund, Ulrica Wilderäng, David Wright

Balancing events, not patients, maximizes power of the logrank test: and other insights on unequal randomization in survival trials

Godwin Yung, Kaspar Rufibach, Marcel Wolbers, Ray Lin, Yi Liu

An alternative to classical intention-to-treat analysis for comparing a time-to-event endpoint in precision oncology trials

Marilena Müller

Proposing a new method to estimate the survival of the Intention-to-Treat population in trials with Two-Stage-Randomization-Design

Dan Huang, Eva Hoster, Stefan Englert, Martin Dreyling, Ulrich Mansmann

RCT for recurrent events

Thomas Scheike

Clinical trial simulation: Planning, implementation and validation principles

Kim May Lee, Babak Choodari-Oskooei, Michael J. Grayling, Peter Jacko, Peter K. Kimani, Aritra Mukherjee, Philip Pallmann, Tom Parke, David S. Robertson, Ziyan Wang, Christina Yap, Thomas Jaki

Early Phase Dose-Finding Designs for CAR-T cell Therapies

Weishi Chen, Pavel Mozgunov, Xavier Paoletti

Fast approximation of the operating characteristics in clinical trials

Susanna Gentile, Daniel Schwartz, Riddhiman Saha, Lorenzo Trippa

Quantifying the effects of screening – a re-randomisation approach

Vichithranie Wasantha Madurasinghe, Bethany Shinkins, Keith R Abrams, Sian Taylor-phillips

From Methodology to Mindset: Implementing Quantitative Decision-Making Framework into Early Development Clinical Trials

Stefan Englert, Leen Slaets, Lilla Di Scala

Distributive randomization: a pragmatic design to evaluate multiple simultaneous interventions in a clinical trial

Skerdi Haviari, France Mentré

Forced Randomisation – a powerful, sometimes controversial, tool for multi-centre RCTs

Johannes Krisam, Kerstine Carter, Olga Kuznetsova, Volodymyr Anisimov, Colin Scherer, Yevgen Ryeznik, Oleksandr Sverdlov

Type I error rate control in adaptive platform trials when including non-concurrent controls in the presence of time trend

Jinyu Zhu, Peter Kimani, Nigel Stallard, Andy Metcalfe, Jeremy Chataway, Keith Abrams

Data-driven controlled subgroup selection in clinical trials

Manuel M. Müller, Konstantinos Sechidis, Björn Bornkamp, Frank Bretz, Fang Wan, Wei Liu, Henry W. J. Reeve, Timothy I. Cannings, Richard J. Samworth

Debunking the myth: Random block sizes do not decrease selection biases in open-label clinical trials

Wenle Zhao

Innovative clinical trial approach for evaluating digital medical devices under European fast-track regulatory frameworks

Moreno Ursino, Sandrine Boulet, Raphaël Porcher, Edouard Lhomme, Florence Francis-Oliviero, Gaël Varoquaux, Florence Saillour, Corinne Collignon, Rodolphe Thiébaut, Sarah Zohar

Using only an early outcome for interim decisions regarding treatment effect on a long-term endpoint: a practical implementation

Tomasz Burzykowski, Leandro Garcia Barrado

Calibrated Risk-Scale: A Proposed Futility Design Framework to Enhance Portfolio-Level Profitability and Performance

Nima Shariati

Interim analysis under treatment effect heterogeneity

Audrey Boruvka

When to Schedule the Interim Analysis in the Presence of Missing Data?

Neža Dvoršak, Jianmei Wang, Thomas Burnett, Christopher Jennison, Robin Mitra

How Biostatistical Methods Mature: Understanding the Four Phases of Methodological Research

Georg Heinze

Phases of development of the Weighted Cumulative Exposure modeling

Michal Abrahamowicz

Phases of development of the Multivariable Fractional Polynomial Interaction (MFPI) procedure

Willi Sauerbrei

Will Net Benefit trump Net Reclassification Index as a measure for incremental value of markers in prediction models? Historical perspective

Ewout Steyerberg

Mission impossible? Specifying target estimands for long-term risks and benefits of novel therapies

Rima Izem

An overview on recent works and activities of the STRATOS topic group TG3 “Initial data analysis”

Carsten. O. Schmidt

An overview and recent developments of the STRATOS Open Science panel

Sabine Hoffmann

Adjusting for Covariate Measurement Error in Non-Linear Regression: Comprehensive Phase 2 Results from the STRATOS TG2-TG4 Study

Aris Perporoglou