Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Avenue, Boston, MA 02215, USA.
Nat Rev Clin Oncol. 2011 Aug 2;8(10):620-5. doi: 10.1038/nrclinonc.2011.114.
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.
越来越多的临床试验纳入了转化研究问题，旨在确定对正在研究的药物的反应或耐药的生物标志物。生物标志物检测可能需要在治疗前、治疗期间或肿瘤进展时通过研究性活检采集组织样本。这些活检样本通常不会直接使患者受益，并且由于任何手术程序都存在风险，因此当参与者参加临床试验取决于他们同意进行研究性活检时，就会引起伦理问题。在这篇观点文章中，我们提出了强制性研究性活检的基本原理，并提出了标准化建议，以确保继续以科学和伦理的严谨性设计高质量、以患者为中心的临床试验。
