5 papers
Evidence-to-Decision (E2D): Structuring Action-Specific Evidence for Early-Phase Oncology Development
Haitao Pan
Early-phase oncology evidence is often summarized by asking whether a treatment is promising, but an encouraging signal can support several different next studies. We propose Evide…
Qualify-Then-Borrow: A Five-Step Framework for Bayesian Borrowing Beyond Outcome Agreement
Haitao Pan
PURPOSE: Dynamic Bayesian borrowing methods adapt the contribution of external information according to agreement or disagreement with current data. Qualify-Then-Borrow (QTB) makes…
Interim Monitoring as an Information-Time Alignment Problem: The WCR Framework for Time-to-Event Trials
Haitao Pan, Zhongheng Cai
Interim monitoring in time-to-event trials must balance inferential maturity with operationally meaningful timing. Event-driven designs align analyses with event accumulation but c…
A Bayesian Optimal Phase II Design for Randomized Immunotherapy Trials with Delayed Treatment Effects
Zhongheng Cai, Haitao Pan
Immunotherapy has transformed cancer treatment, yet its delayed therapeutic effects often lead to non-proportional hazards, rendering many conventional phase II designs underpowere…
A Novel Bayesian Extrapolation Design for Assessing Equivalence in Exposure-Response Curves between Pediatric and Adult Populations
Zhongheng Cai, Lian Ma, Jingjing Ye +1
Development of effective treatments in pediatric population poses unique scientific and ethical challenges in addition to the small population. In this regard, both the U.S. and E.…