What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?
What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?
复制标题
DOI：
10.1200/jop.18.00092
复制
发表时间：
2018-11-01
影响因子：
--
通讯作者：
Chen, Alice P.
中科院分区：
文献类型：
--
作者：
Ferry-Galow, Katherine, V;Datta, Vivekananda;Chen, Alice P.
临床试验中收集的研究性活检标本通常要求超出诊断性肿瘤活检标本的要求。研究性活组织检查支持假说驱动的药物开发、分子靶向抗癌剂的药效学评估，以及越来越多的精确医学的基因组评估;因此，活检标本的质量或数量不足会损害研究的科学价值和投入的资源，以及每位患者对临床试验的贡献和潜在受益。方法为了提高研究活检标本的质量，我们咨询了其他转化肿瘤学团队，并回顾了当前的最佳实践。结果在这些建议中，包括改善肿瘤学家和介入放射学家之间的沟通，提供关于标本充足性的反馈，增加学术认可和对放射学家收集和保存研究活检标本所需的时间投资的财政支持，和提高实时评估的组织quality.ConclusionImplementing这些建议在国家癌症研究所的发展治疗诊所已明显提高质量的活检标本收集;在大型临床癌症中心之外更广泛地传播这些建议是可能的，并且在改善临床研究和最终改善患者护理方面对社区是有价值的。
PurposeResearch biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient's contribution to and potential benefit from a clinical trial.MethodsTo improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices.ResultsAmong the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality.ConclusionImplementing these recommendations at the National Cancer Institute's Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.