A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Laleh Amiri‐Kordestani(United States Food and Drug Administration), Julia A. Beaver(Center for Drug Evaluation and Research), Amna Ibrahim(Beni-Suef University), Diqiong Xie(United States Food and Drug Administration), Shenghui Tang(United States Food and Drug Administration), Richard Pazdur(United States Food and Drug Administration), Erik Bloomquist(Center for Drug Evaluation and Research), Sara M. Tolaney(Harvard University), Marc R. Theoret(United States Food and Drug Administration), Eric P. Winer(University of Vermont), Kirsten B. Goldberg(United States Food and Drug Administration), R. Sridhara(United States Food and Drug Administration)
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