External control arms in oncology: current use and future directions von Mishra-Kalyani, P.S., Amiri Kordestani, L., 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.

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Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer von Blumenthal, G.M., Gong, Y., Kehl, K., Mishra-Kalyani, P., Goldberg, K.B., Khozin, S., Kluetz, P.G., Oxnard, G.R., Pazdur, R.

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Optimizing Dosing of Oncology Drugs von Minasian, L, Rosen, O, Auclair, D, Rahman, A, Pazdur, R, Schilsky, R L

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Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy von McCoach, C.E., Blumenthal, G.M., Zhang, L., Myers, A., Tang, S., Sridhara, R., Keegan, P., Pazdur, R., Doebele, R.C., Kazandjian, D.

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The role of nonrandomized trials in the evaluation of oncology drugs von Simon, R, Blumenthal, GM, Rothenberg, ML, Sommer, J, Roberts, SA, Armstrong, DK, LaVange, LM, Pazdur, R

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FDA Drug Approval Summary: Azacitidine (5‐azacytidine, Vidaza™) for Injectable Suspension von Kaminskas, Edvardas, Farrell, Ann T., Wang, Yong‐Cheng, Sridhara, Rajeshwari, Pazdur, Richard

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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 von 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.

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Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science von Blumenthal, GM, Goldberg, KB, Pazdur, R

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Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007 von Sridhara, Rajeshwari, Johnson, John R., Justice, Robert, Keegan, Patricia, Chakravarty, Aloka, Pazdur, Richard

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Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy von McCoach, C E, Blumenthal, G M, Zhang, L, Myers, A, Tang, S, Sridhara, R, Keegan, P, Pazdur, R, Doebele, R C, Kazandjian, D

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Corrigendum to “Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria”: [Annals of Oncology 32 (2021) 950-953]... von 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.

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Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria von 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.

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A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer von Raju, GK, Gurumurthi, K, Domike, R, Kazandjian, D, Blumenthal, G, Pazdur, R, Woodcock, J

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Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer von Prowell, Tatiana M, Pazdur, Richard

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Anticancer Drug Discovery and Development Throughout the World von SCHWARTSMANN, G, RATAIN, M. J, DI LEONE, L, CRAGG, G. M, WONG, J. E, SAIJO, N, PARKINSON, D. R, FUJIWARA, Y, PAZDUR, R, NEWMAN, D. J, DAGHER, R

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Immunotherapy Combinations in Multiple Myeloma — Known Unknowns von Gormley, Nicole J, Pazdur, Richard

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Response Rates, Survival, and Chemotherapy Trials von Pazdur, R

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Docetaxel von CORTES, J. E, PAZDUR, R

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Accelerated Approval of Oncology Products: A Decade of Experience von Dagher, Ramzi, Johnson, John, Williams, Grant, Keegan, Patricia, Pazdur, Richard

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Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration von TALARICO, Lilia, GANG CHEN, PAZDUR, Richard

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