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Bellinda L. King-Kallimanis

Center for Drug Evaluation and Research

4

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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.

2021 Lancet Oncology
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Demystifying the estimand framework: a case study using patient-reported outcomes in oncology

2020 Lancet Oncology
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US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

2019 Lancet Oncology
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FDA Approval Summary: Pertuzumab for adjuvant treatment of HER2-positive early breast cancer

2018 Clinical Cancer Research
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