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SCI 11 February 2025 Novel clinical trial designs emerging from the molecular reclassification of cancer (CA Cancer J Clin, IF: 503.1) Nikanjam M, Kato S, Allen T, et al: Novel clinical trial designs emerging from the molecular reclassification of cancer. CA Cancer J Clin 10.3322/caac.21880, 2025 Next-generation sequencing has revealed the disruptive reality that advanced/metastatic cancers have complex and individually distinct genomic landscapes, necessitating a rethinking of treatment strategies and clinical trial designs. Indeed, the molecular reclassification of cancer suggests that it is the molecular underpinnings of the disease, rather than the tissue of origin, that mostly drives outcomes. Consequently, oncology clinical trials have evolved from standard phase 1, 2, and 3 tissue-specific studies; to tissue-specific, biomarker-driven trials; to tissue-agnostic trials untethered from histology (all drug-centered designs); and, ultimately, to patient-centered, N-of-1 precision
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