Biomarker-Driven Phase 3 Clinical Trial Enrollment With a Hybrid Approach of Qualified Local & Central Laboratory Developed Tests
- The ENHANCE-02 trial enrolled Acute Myeloid Leukemia subjects with TP53 mutation
- Assay concordance was estimated for the collection of local LDTs and a planned CDx assay
- Effects of this approach on enrollment speed and simulated trial efficacy analysis were examined