期刊
NATURE REVIEWS CLINICAL ONCOLOGY
卷 8, 期 10, 页码 620-U1539出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/nrclinonc.2011.114
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资金
- NCI NIH HHS [K12 CA133250] Funding Source: Medline
Increasingly, clinical trials incorporate translational research questions aimed at identifying biomarkers of response or resistance to agents under investigation. Biomarker assays can require tissue samples to be collected through a research biopsy before therapy, during treatment, or at the time of tumor progression. Such biopsy samples will generally not provide a direct benefit to the patient and, given the risks associated with any surgical procedure, ethical concerns have been raised when the participant's enrollment on a clinical trial depends on their consent to undergo a research biopsy. In this Perspectives article, we present the rationale for mandatory research biopsies and offer suggestions for standardization to ensure that high-quality, patient-centered, clinical trials continue to be designed with scientific and ethical rigor. Olson, E. M. et al. Nat. Rev. Clin. Oncol. 8, 620-625 (2011); published online 2 August 2011; doi:10.1038/nrclinonc.2011.114
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