Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker.

@article{Beckman2016AdaptiveDF,
  title={Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker.},
  author={Robert A. Beckman and Zoran Antonijevic and Rasika Kalamegham and Cong Chen},
  journal={Clinical pharmacology and therapeutics},
  year={2016},
  volume={100 6},
  pages={617-625}
}
Increasingly, tumors are defined on a molecular basis rather than only on histology, and targeted agents, which address these molecular subtypes, are being approved. This profusion of molecular subtypes creates "rare" diseases as subsets of common cancers, leading to difficulties in enrolling sufficiently large cohorts for confirmatory trials. However, if the molecular subtype is shared across various histologies, these may be pooled into a basket trial. To date, basket trials have been… CONTINUE READING