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UID:20251103T154506EST-4961NxkzdC@132.216.98.100
DTSTAMP:20251103T204506Z
DESCRIPTION:Ting Ye\, PhD\n\nAssistant Professor\, Department of Biostatist
 ics |\n	University of Washington\n\nWHEN: Wednesday\, November 12\, 2025\, 
 from 3:30 to 4:30 p.m.\n	WHERE: Hybrid | 2001 9IÖÆ×÷³§Ãâ·Ñ College Avenue\, Rm 11
 40\; Zoom\n	NOTE: Ting Ye will be presenting from Seattle\n	 \n\nAbstract\n
 \nA master protocol trial is an innovative clinical trial design that uses
  a single overarching protocol to evaluate multiple treatments\, diseases\
 , or disease subtypes\, where participants are often randomized to differe
 nt subsets of treatment arms based on individual characteristics\, enrollm
 ent timing\, and treatment availability. While offering increased flexibil
 ity\, this constrained and non-uniform treatment assignment poses inferent
 ial challenges\, with two fundamental ones being the precise definition of
  treatment effects and robust\, efficient inference on these effects. Such
  challenges arise primarily because some commonly used analysis approaches
  may target estimands defined on populations inadvertently depending on ra
 ndomization ratios or trial operational format\, thereby undermining inter
 pretability. This article\, for the first time\, presents a formal framewo
 rk for constructing a clinically meaningful estimand with precise specific
 ation of the population of interest. Specifically\, the proposed entire co
 ncurrently eligible (ECE) population not only preserves the integrity of r
 andomized comparisons but also remains invariant to both the randomization
  ratio and trial operational format. Then\, we develop weighting and post-
 stratification methods to estimate treatment effects under the same minima
 l assumptions used in traditional randomized trials. We also consider mode
 l-assisted covariate adjustment to fully unlock the efficiency potential o
 f master protocol trials while maintaining robustness against model misspe
 cification. The SIMPLIFY trial\, a master protocol assessing continuation 
 versus discontinuation of two common therapies in cystic fibrosis\, is uti
 lized to further highlight the practical significance of this research. Al
 l analyses are conducted using the R package RobinCID..\n\n\n	Speaker Bio\n
 \nPlease visit website: https://www.ting-ye.com/\n
DTSTART:20251112T203000Z
DTEND:20251112T213000Z
SUMMARY:From Estimands to Robust Inference of Treatment Effects in Master P
 rotocol Trials
URL:/epi-biostat-occh/channels/event/estimands-robust-
 inference-treatment-effects-master-protocol-trials-368549
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