5 citations · 5 across the 6 of their papers we have counts for
8 papers · 1 filter
BOP2-ENR: a Bayesian optimal phase II design for adaptive enrichment with family-wise error rate control and a bound on joint-claim power
Kentaro Takeda, Belay B. Yimer, Masahiro Kojima
The Bayesian optimal phase II (BOP2) design accommodates simple and complex endpoints but does not address biomarker-guided enrichment or multiplicity control across pooled and sub…
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…
Finite-Boundary Reduction and Exact Verification of Strong Familywise Error in Active-Count-Coupled Multi-Arm Efficacy-Toxicity Monitoring
Masahiro Kojima, Hisato Sunami, Kentaro Takeda
Randomized dose-optimization trials may screen several candidate doses using binary efficacy and toxicity outcomes. A dose is inadmissible if efficacy is insufficient or toxicity i…
A staggered seamless dose-optimization design for co-developing monotherapy and combination therapy
Masahiro Kojima, Kentaro Takeda, Ying Yuan
Contemporary oncology drug development increasingly requires efficient dose-optimization strategies that evaluate monotherapy (Mono) and combination therapy (Combo) while balancing…
A seamless dose-optimization design for monotherapy and combination therapy
Kentaro Takeda, Masahiro Kojima
The emergence of molecular-targeted agents and immune-oncology therapies has fundamentally transformed oncology drug development, necessitating evolution beyond traditional dose-fi…
Hybrid Non-informative and Informative Prior Model-assisted Designs for Mid-trial Dose Insertion
Kana Yamada, Hisato Sunami, Kentaro Takeda +2
In oncology phase I trials, model-assisted designs have been increasingly adopted because they enable adaptive yet operationally simple dose adjustment based on accumulating safety…
BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity
Kai Chen, Yixuan Zhao, Kentaro Takeda +1
The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maxim…
ROMI: A Randomized Two-Stage Basket Trial Design to Optimize Doses for Multiple Indications
Shuqi Wang, Peter F. Thall, Kentaro Takeda +1
Optimizing doses for multiple indications is challenging. The pooled approach of finding a single optimal biological dose (OBD) for all indications ignores that dose-response or do…