4 papers
PKComb-BOIN12: A Pharmacokinetically Guided Bayesian Design for Dose Optimisation in Oncology Drug-Combination Trials
Jieqi Tu, Ruitao Lin, Ayon Mukherjee
Dose optimisation of two-agent combinations in early-phase oncology trials must jointly balance toxicity, efficacy, and pharmacologically meaningful drug exposure, yet existing mod…
Optimal Biological Dose Combination Finding: A Design Roadmap and Robust Cross-Indication Bayesian Borrowing
Ayon Mukherjee, Kentaro Takeda, James M. S. Wason
Early-phase combination oncology trials increasingly seek the optimal biological dose combination (OBDC) rather than a maximum tolerated dose combination, in line with the FDA's Pr…
Estimands for Randomized Discontinuation Designs in Oncology
Ayon Mukherjee, Oleksandr Sverdlov, Ngoc-Thuy Ha +1
Randomized discontinuation design (RDD) is an enrichment strategy commonly used to address limitations of traditional placebo-controlled trials, particularly the ethical concern of…
Estimands for Early Phase Dose Optimization Trials in Oncology
Ayon Mukherjee, Jonathan L. Moscovici, Zheng Liu
Phase I dose escalation trials in oncology generally aim to find the maximum tolerated dose (MTD). However, with the advent of molecular targeted therapies and antibody drug conjug…