Biomarker-Driven Clinical Trials In Oncology: Enrichment, Stratification, All-Comers & Basket

By Paul Steven

In the high-stakes environment of oncology drug development, the trajectory of a clinical program is often etched into its earliest blueprints. As immuno-oncology combinations grow more sophisticated and regulatory initiatives like Project Optimus shift the focus toward nuanced dose optimization, the "all-comers" approach is no longer a default setting. Choosing between enrichment, stratification, or tumor-agnostic basket designs requires a delicate balance between signal clarity and market reach. An enrichment design might offer the straightest line to proving efficacy, but it risks a narrow regulatory label. Conversely, while basket trials offer immense operational efficiency by targeting mutations across multiple cancer types, they demand high-level statistical rigor and adaptive frameworks. Understanding these four core study designs is essential for aligning clinical operations with data science. By integrating assay validation and sample logistics into the initial strategy, sponsors can avoid the common pitfalls of diluted signals or retrospective ambiguity, ensuring the right therapy reaches the patients most likely to benefit.