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Qiuxin Gao

Publications and source records attributed to Qiuxin Gao.

2 recordsLinked to original sources

WOW: WAIC-Optimized Gating of Mixture Priors for External Data Borrowing

The integration of external data using Bayesian mixture priors has become a powerful approach in clinical trials, offering significant potential to improve trial efficiency. Despite their strengths in analytical tractability and practical flexibility, existing methods such as the robust meta-analytic-predictive (rMAP) and self-adapting mixture (SAM) often presume borrowing without rigorously assessing whether external information is appropriate to incorporate. When external and concurrent data are discordant, excessive borrowing can bias estimation and lead to misleading conclusions. To address this, we introduce WOW, a Kullback-Leibler-based gating strategy guided by the widely applicable information criterion (WAIC). Within the mixture-prior framework, WAIC-Optimized Weighting (WOW) conducts a preliminary compatibility assessment between external and concurrent trial data to determine eligibility for borrowing. Only if this gating criterion is satisfied does borrowing proceed; a downstream mixture prior procedure, using user-specified fixed or adaptive weights, can then be applied to determine the amount of borrowing. Simulation studies demonstrate that incorporating the WOW strategy before Bayesian mixture prior borrowing methods effectively mitigates excessive borrowing and improves estimation accuracy. A real-data illustration further highlights the feasibility and interpretability of the proposed gate-then-borrow strategy. By providing a practical safeguard against inappropriate borrowing, WOW strengthens the reliability of mixture-prior methods and supports better decision-making in clinical trials.

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RESOLVE-IPD: High-Fidelity Individual Patient Data Reconstruction and Uncertainty-Aware Subgroup Meta-Analysis

Individual patient data (IPD) from oncology trials are essential for reliable evidence synthesis but are rarely publicly available, necessitating reconstruction from published Kaplan-Meier (KM) curves. Existing reconstruction methods suffer from digitization errors, unrealistic uniform censoring assumptions, and the inability to recover subgroup-level IPD when only aggregate statistics are available. We developed RESOLVE-IPD, a unified computational framework that enables high-fidelity IPD reconstruction and uncertainty-aware subgroup meta-analysis to address these limitations. RESOLVE-IPD comprises two components. The first component, High-Fidelity IPD Reconstruction, integrates the VEC-KM and CEN-KM modules: VEC-KM extracts precise KM coordinates and explicit censoring marks from vectorized figures, minimizing digitization error, while CEN-KM corrects overlapping censor symbols and eliminates the uniform censoring assumption. The second component, Uncertainty-Aware Subgroup Recovery, employs the MAPLE (Marginal Assignment of Plausible Labels and Evidence Propagation) algorithm to infer patient-level subgroup labels consistent with published summary statistics (e.g., hazard ratio, median overall survival) when subgroup KM curves are unavailable. MAPLE generates ensembles of mathematically valid labelings, facilitating a propagating meta-analysis that quantifies and reflects uncertainty from subgroup reconstruction. RESOLVE-IPD was validated through a subgroup meta-analysis of four trials in advanced esophageal squamous cell carcinoma, focusing on the programmed death ligand 1 (PD-L1)-low population. RESOLVE-IPD enables accurate IPD reconstruction and robust, uncertainty-aware subgroup meta-analyses, strengthening the reliability and transparency of secondary evidence synthesis in precision oncology.

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