Akihiro Hirakawa

BOIN12-PFS: A Bayesian Optimal Interval Phase I/II Design Incorporating Progression-Free Survival Endpoint.

Modern oncology drug development is increasingly focused on identifying the optimal biological dose (OBD) rather than just the maximum tolerated dose (MTD). Early-phase oncology trials have conventionally relied on short-term endpoints, such as overall response rate (ORR), to evaluate efficacy. However, there is a grow...

Complete remission and relapse in the treatment of idiopathic inflammatory myopathies: a retrospective cohort study.

Time-varying prognostic value of circulating tumor DNA in urothelial carcinoma: a systematic review and reconstructed patient-data meta-analysis.

Circulating tumor DNA (ctDNA) increasingly guides adjuvant therapy and surveillance in urothelial carcinoma (UC), yet whether its prognostic effect is adequately summarized by a single pooled hazard ratio (HR), which assumes proportional hazards (PH), has not been formally evaluated. We searched five sources for studie...