34 citations · 66 across the 18 of their papers we have counts for
4 papers · 1 filter
Implementation of ICH E9 (R1): a few points learned during the COVID-19 pandemic
Yongming Qu, Ilya Lipkovich
The current COVID-19 pandemic poses numerous challenges for ongoing clinical trials and provides a stress-testing environment for the existing principles and practice of estimands…
Understanding and adjusting the selection bias from a proof-of-concept study to a more confirmatory study
Yongming Qu, Yu Du, Ying Zhang +1
It has long been noticed that the efficacy observed in small early phase studies is generally better than that observed in later larger studies. Historically, the inflation of the…
Defining Estimands Using a Mix of Strategies to Handle Intercurrent Events in Clinical Trials
Yongming Qu, Linda Shurzinske, Shanthi Sethuraman
Randomized controlled trials (RCT) are the gold standard for evaluation of the efficacy and safety of investigational interventions. If every patient in an RCT were to adhere to th…
Implementation of Tripartite Estimands Using Adherence Causal Estimators Under the Causal Inference Framework
Yongming Qu, Junxiang Luo, Stephen J. Ruberg
Intercurrent events (ICEs) and missing values are inevitable in clinical trials of any size and duration, making it difficult to assess the treatment effect for all patients in ran…