Quality assurance in clinical trials—the role of pathology
作者： Christoph Röcken
DOI: 10.1007/S00428-015-1857-X
关键词:
摘要: In the last two decades, our knowledge about cancer genetics and biology increased exponentially. Deep sequencing now allows rapid cost-effective analysis of entire genomes. Dysregulation cell growth, survival, tissue homeostasis, immune surveillance have been recognized as hallmarks cancer. parallel, diagnostic surgical pathology has harmonized consensus criteria for classification developed by initiatives World Health Organization, International Agency Research on Cancer, Union Cancer Control. Pharmaceutical companies novel drugs targeting specific molecules in signaling pathways, which allowed development concept precision medicine. Now, we are facing a large number clinical trials bring together these advances will explore efficacy treatment regimens. Assessment new drug is often coupled with simultaneous assessment capacity tissue-based biomarkers to predict response individual patients (companion diagnostics/precision medicine). Patients histologically similar tumors might respond differently same drug. This review summarizes diverse roles played pathologists involved trials, special focus quality assurance diagnostic, laboratory, reporting standards.
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