Author

Wen-Wee Ma

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Open access Oct 2026

Early-Phase Drug Development in Rare Cancers: A Decade of Progress and Future Directions

Rare cancers represent a substantial health burden, comprising 25% of cancer mortality. Early-phase oncology trials are essential for rare cancers, where limited patient numbers, biological heterogeneity, and the absence of established standards of care necessitate innovative approaches to drug development. Advances in...

Y. Myat, K. Thein, Lujain Mahmood et al. · Cancers · 0 citations

Sep 2026

A Seamless Phase I/II Design With Randomization for Biomarker-Guided Oncology Trials.

The FDA's Project Optimus CALLS for randomized exploration of multiple doses to better refine selection of the optimal biologic dose (OBD). Project FrontRunner encourages the use of randomized controlled trials earlier in the drug development process. We propose a seamless three-stage trial design that addresses both g...

Emily C. Zabor, Sneha Govande, Wen-Wee Ma et al. · Pharmaceutical statistics · 0 citations