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Cancer clinical trials in the era of genomic signatures: Biomedical innovation, clinical utility, and regulatory-scientific hybrids

11 Apr 2011

Abstract excerpt

The paper examines two large-scale, North American and European clinical trials designed to validate two commercially available genomic tumor signatures that predict a patient's risk of breast cancer recurrence and response to chemotherapy. The paper builds on empirical evidence from the two trials to explore the emergence of diverse regulatory-scientific hybrids; that is, the paper discusses configurations of...

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PMID: 21998967
DOI: 10.1177/0306312711398741

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