Smaller, Faster & More Effective: Clinical Trial Enrichment Using Circulating Biomarkers
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Diseases are singularly defined but often represent varied groupings of contributing factors and pathways that ultimately produce a shared pathology. Heterogeneous molecular pathogenesis creates heterogeneity in treatment responsiveness, which in turn drives up clinical trial size, timing, cost, and failure rates. For agents that ultimately achieve FDA approval, generally 40% of patients in a trial are found to be “responders”, with over half or more of all enrolled participants having minimal or no therapy response. Without strong understanding of underlying disease biology, a wide net must be cast to ensure inclusion of enough individuals likely to benefit from treatment.
See examples in which these biomarkers have been applied to drive smaller, faster, and cheaper clinical trials, as well as to prevent potential non-responder patients from being exposed to unnecessary drugs. Ultimately these approaches enable trials to align the right patient with the right disease pathway and the most effective therapy.