Repeated ordinal outcomes capture how treatment benefits and harms evolve over time. We develop doubly robust estimation and inference for visit-specific win probabilities and their prespecified weighted summaries, with Desirability of Outcome Ranking as a motivating example. Baseline confounding is addressed through a...
Shu-Han Liu, Maria Kudela, Margaret Gamalo et al.· 0 citations
Artificial intelligence (AI) and machine learning (ML) are reshaping the pharmaceutical lifecycle, from discovery and clinical development through manufacturing and regulatory review to safety surveillance and health economics, creating evidentiary challenges that predictive performance alone cannot address. This revie...
Xin Luo, Margaret Gamalo, Achilleas Livieratos et al.· 0 citations
Randomized trials support causal inference, but differences between trial and target populations can limit the transportability of treatment effects to real-world settings. Many existing approaches model the propensity of trial participation and can therefore be sensitive to model misspecification and weak overlap of t...
Anik Burman, Margaret Gamalo, Promit Ghosal et al.· 0 citations
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