PO.RSP01.01 · 监管科学与政策
Regulatory Science and Policy
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1392 · PDF 一项混合方法评估:考察多层次障碍与促进因素以指导在大型综合癌症中心推进公平临床试验入组的实施策略 A mixed-methods evaluation of multilevel barriers and facilitators to inform implementation strategies for advancing equitable clinical trial accrual in a large comprehensive cancer center Morgan Gill, Syma Iqbal, Vibha Kodancha, Emmeline Friedman, Diana L. Hanna, Chanita Hughes-Halbert, Anthony El-Khoueiry, Jennifer Tsui
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1393 · PDF 一项前瞻性实施研究的设计:评估AI辅助工作流程干预对提高乳腺癌临床试验参与率的疗效 Design of a prospective implementation study to evaluate the efficacy of an AI-assisted workflow intervention to increase breast cancer clinical trial participation Jacob T. Rosenthal, Emma Hahesy, Sulov Chalise, Zhigang Zhang, Menglei Zhu, Mert R. Sabuncu, Anyi Li, Lior Zvi Braunstein
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1394 · PDF 活检要求对癌症I期试验患者入组的影响 Effect of biopsy requirement on patient enrollment to phase I trials in cancer Catherine Yang, Mona Yuan, Sebastian Saenz, Marisa Palmeri, Mohammad Ghalib, Dina Oz, Diana Nelson, Rita M. Musanti, Devika Rao, Eugenia Girda, Francis Kang, Sanjay Goel
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1395 · PDF 非小细胞肺癌早期临床试验中心在美国境内外的分布 The distribution of non-small cell lung cancer early phase clinical trial sites within and outside the United States Brittany Avin McKelvey, Luke Saxton-Stivers, Tod Guidry, Andrea E. Ferris
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1396 · PDF 简化临床试验与诊断器械的联合开发:EMA COMBINE 项目试点 Streamlining combined clinical trial and diagnostic device development: The EMA COMBINE Project Pilot Louis-Guillaume Marquier
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1397 · PDF AI 时代的基因组关系隐私:一项范围综述 Genomic Relational Privacy in AI Era: a scoping review Ying Huang, Emily Boja, Jaime Guidry Auvil
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1398 · PDF 撒哈拉以南非洲癌症研究的主题趋势:来自五年机构数据集的洞见 Thematic trends in cancer research from sub-Saharan Africa: Insights from a five-year institutional dataset Adedayo Joseph, Funmilayo Aina-Tolofari, Ayodeji O. Ojetunde, Philip Ejeikwu, Lilian Ekpo, Tolulope Adewole
- 1399 1399 SFDA 肿瘤与血液学科十六个月监管与科学活动分析 Analysis of regulatory and scientific activities of SFDA oncology and hematology section in sixteen months Tariq Hassan AL Qurayshah, SFDA Oncology & Hematology Group
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1400 · PDF 应对靶向肿瘤学试验中的欧盟 IVDR 挑战 Addressing the EU IVDR challenge in targeted oncology trials Margaret Curnutte
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1401 · PDF 用于新辅助乳腺癌试验中生存期替代终点预测的一种新型统计框架 A novel statistical framework for surrogate endpoint prediction of survival in neoadjuvant breast cancer trials Keli S. Santos-Parker, Jessica R. Santos-Parker, W. Fraser Symmans, Laura J. Esserman, Christina Yau, Angie DeMichele, Laura van't Veer, Doug Yee, Fabien Reyal, Helena Earl, Jean Abraham, David Cameron, Peter Hall, Judy Boughey, Matthew Goetz, Gabe Sonke, Miguel Martín, Sara López-Tarruella, Priyanka Sharma, Rachel Freiberg, Jane Perlmutter, Aditya Bardia, Martin Eklund, Rachel Freiberg, Lajos Pusztai
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1402 · PDF trastuzumab deruxtecan 治疗 HER2 表达的卵巢癌和子宫内膜癌的真实世界临床结局 Real world clinical outcomes with trastuzumab deruxtecan in HER2 expressing ovarian and endometrial cancer Oladunni Alomaja, Jordyn F. Silverstein, Maryam Hajiabbasi, Eliya Shachar, Shivani Thaker, Beth Karlan, Aditya Bardia, Gottfried E. Konecny, First two authors contributed equally and share first authorship