Countering Imprecision in Precision Medicine

Despite substantial promise, precision medicine has been plagued by three inherent scientific obstacles: pivotal trials cannot be agnostic about underlying biological theories, interventions are complex “biomarker ensembles” with multiple components and degrees of uncertainty, and no single stakeholder controls the biomarkers or coordinates the research program. The authors argue that meaningful progress requires new mechanisms of scientific oversight, given that many commercially available biomarker diagnostics have not been adequately validated and even seemingly successful precision medicines like trastuzumab have been characterized by uncertainty about diagnostic test interpretation.