未登录 Evaluation of somatic copy number variation detection by NGS technologies and bioinformatics tools on a hyper-diploid cancer genome Masood, Daniall; Ren, Luyao; Nguyen, Cu; Brundu, Francesco G.; Zheng, Lily; Zhao, Yongmei; Jaeger, Erich; Li, Yong; Cha, Seong Won; Halpern, Aaron; Truong, Sean; Virata, Michael; Yan, Chunhua; Chen, Qingrong; Pang, Andy; Alberto, Reyes; Xiao, Chunlin; Yang, Zhaowei; Chen, Wanqiu; Wang, Charles; Cross Jr, Frank; Catreux, Severine; Shi, Leming; Beaver, Julia A.; Xiao, Wenming; Meerzaman, Daoud M. 分享 收藏
A US Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma Lee, Daniel; Gittleman, Haley; Weinstock, Chana; Suzman, Daniel; Bloomquist, Erik; Agrawal, Sundeep; Brave, Michael; Brewer, Jamie; Fallah, Jaleh; Singh, Harpreet; Tang, Shenghui; Ibrahim, Amna; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh 分享 收藏
Trends in the approval of cancer therapies by the FDA in the twenty-first century 21世纪FDA批准癌症治疗的趋势 Scott, Emma C.; Baines, Andrea C.; Gong, Yutao; Moore Jr, Rodney; Pamuk, Gulsum E.; Saber, Haleh; Subedee, Ashim; Thompson, Matthew D.; Xiao, Wenming; Pazdur, Richard; Rao, V. Ashutosh; Schneider, Julie; Beaver, Julia A. 分享 收藏
Feasibility of generating an external control comparator using RWD by matching with previously conducted RCTs: CDK4/6 Inhibitors for the treatment of Metastatic Breast Cancer Osgood, Christy; Fan, Jiaxin; Gao, Xin; Keane, Catherine; Bryan, Jonathan; Roose, James P.; Bloomquist, Erik; Torres, Aracelis; Baxi, Shrujal; Nussbaum, Nathan; Rizvi, Fatima; Tang, Shenghui; Nunes, Irene; Beaver, Julia; Rivera, Donna R.; Howie, Lynn; Paliwal, Prashni; Amiri-Kordestani, Laleh 分享 收藏
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External control arms in oncology: current use and future directions Mishra-Kalyani, P. S.; Kordestani, L. Amiri; Rivera, D. R.; Singh, H.; Ibrahim, A.; DeClaro, R. A.; Shen, Y.; Tang, S.; Sridhara, R.; Kluetz, P. G.; Concato, J.; Pazdur, R.; Beaver, J. A. 分享 收藏
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Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria (vol 32, pg 950, 2021) Gao, J. J.; Krol, D.; Narayan, P.; Cardoso, F.; Regan, M. M.; Goetz, M. P.; Hurvitz, S. A.; Mauro, L.; Hodgdon, C.; Miller, C. P.; Booth, B.; Bloomquist, E.; Ison, G.; Osgood, C.; Bhatnagar, V.; Fashoyin-Aje, L.; Pazdur, R.; Amiri-Kordestani, L.; Beaver, J. A. 分享 收藏
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Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs) Amiri-Kordestani, Laleh; Gao, Xin; Baxi, Shrujal; Bloomquist, Erik; Bryan, Jonathan; Howie, Lynn; Keane, Catherine; Kluetz, Paul G.; Osgood, Christy; Paliwal, Prashni; Rivera, Donna R.; Roose, James; Schneider, Julie; Singh, Harpreet; Tang, Shenghui; Zhang, Lijun; Beaver, Julia A. 分享 收藏
Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer Mason, Jeremy; Gong, Yutao; Amiri-Kordestani, Laleh; Wedam, Suparna; Gao, Jennifer J.; Prowell, Tatiana M.; Singh, Harpreet; Amatya, Anup; Tang, Shenghui; Pazdur, Richard; Kuhn, Peter; Blumenthal, Gideon M.; Beaver, Julia A. 分享 收藏
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Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop Chang, Elaine; Apolo, Andrea B.; Bangs, Rick; Chisolm, Stephanie; Duddalwar, Vinay; Efstathiou, Jason A.; Goldberg, Kirsten B.; Hansel, Donna E.; Kamat, Ashish M.; Kluetz, Paul G.; Lerner, Seth P.; Plimack, Elizabeth; Prowell, Tatiana; Singh, Harpreet; Suzman, Daniel; Yu, Evan Y.; Zhang, Hui; Beaver, Julia A.; Pazdur, Richard; Weinstock, Chana; Galsky, Matthew D. 分享 收藏
Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials Fallah, Jaleh; Zhang, Lijun; Amatya, Anup; Gong, Yutao; King-Kallimanis, Bellinda; Bhatnagar, Vishal; Weinstock, Chana; Suzman, Daniel L.; Agrawal, Sundeep; Chang, Elaine; Anscher, Mitchell S.; Chi, Dow-Chung; Xu, James X.; Brewer, Jamie R.; Brave, Michael H.; Hadadi, Mehrnoosh; Theoret, Marc R.; Kluetz, Paul G.; Goldberg, Kirsten B.; Ibrahim, Amna; Tang, Shenghui; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh; Singh, Harpreet 分享 收藏
Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria Gao, J. J.; Krol, D.; Narayan, P.; Cardoso, F.; Regan, M. M.; Goetz, M. P.; Hurvitz, S. A.; Mauro, L.; Hodgdon, C.; Miller, C. P.; Booth, B.; Bloomquist, E.; Ison, G.; Osgood, C.; Bhatnagar, V.; Fashoyin-Aje, L.; Pazdur, R.; Amiri-Kordestani, L.; Beaver, J. A. 分享 收藏
US Food and Drug Administration regulatory updates in neuro-oncology 美国食品和药物管理局在神经肿瘤学方面的监管更新 Mehta, Gautam U.; Barone, Amy K.; Bradford, Diana; Larkins, Erin; Kim, Janice; Pai-Scherf, Lee; Jaigirdar, Adnan; Shah, Mirat; Wedam, Suparna; Amiri-Kordestani, Laleh; Theoret, Marc R.; Pazdur, Richard; Beaver, Julia A.; Singh, Harpreet 分享 收藏
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A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials Amiri-Kordestani, L.; Xie, D.; Tolaney, S. M.; Bloomquist, E.; Tang, S.; Ibrahim, A.; Goldberg, K. B.; Theoret, M. R.; Pazdur, R.; Sridhara, R.; Winer, E. P.; Beaver, J. A. 分享 收藏
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