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External control arms in oncology: current use and future directions

Annals of oncology, 2022-04, Vol.33 (4), p.376-383

2022

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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

Annals of oncology, 2019-05, Vol.30 (5), p.830-838

2019

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Optimizing Dosing of Oncology Drugs

Clinical pharmacology and therapeutics, 2014-11, Vol.96 (5), p.572-579

2014

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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

Annals of oncology, 2017-11, Vol.28 (11), p.2707-2714

2017

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The role of nonrandomized trials in the evaluation of oncology drugs

Clinical pharmacology and therapeutics, 2015-05, Vol.97 (5), p.502-507

2015

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FDA Drug Approval Summary: Azacitidine (5‐azacytidine, Vidaza™) for Injectable Suspension

The oncologist (Dayton, Ohio), 2005-03, Vol.10 (3), p.176-182

2005

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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

Annals of oncology, 2020-12, Vol.31 (12), p.1704-1708

2020

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Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science

Clinical pharmacology and therapeutics, 2017-05, Vol.101 (5), p.572-574

2017

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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

JNCI : Journal of the National Cancer Institute, 2010-02, Vol.102 (4), p.230-243

2010

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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

Annals of oncology, 2019-03, Vol.30 (3), p.492-492

2019

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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]

Annals of oncology, 2022-03, Vol.33 (3), p.356-356

2022

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

Annals of oncology, 2021-08, Vol.32 (8), p.950-953

2021

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A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

Clinical pharmacology and therapeutics, 2016-12, Vol.100 (6), p.672-684

2016

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Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

The New England journal of medicine, 2012-06, Vol.366 (26), p.2438-2441

2012

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Anticancer Drug Discovery and Development Throughout the World

Journal of clinical oncology, 2002-09, Vol.20 (suppl 1), p.47s-59s

2002

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Response Rates, Survival, and Chemotherapy Trials

JNCI : Journal of the National Cancer Institute, 2000-10, Vol.92 (19), p.1552-1553

Pazdur, R

2000

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Immunotherapy Combinations in Multiple Myeloma — Known Unknowns

The New England journal of medicine, 2018-11, Vol.379 (19), p.1791-1795

2018

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Docetaxel

Journal of clinical oncology, 1995-10, Vol.13 (10), p.2643-2655

1995

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Accelerated Approval of Oncology Products: A Decade of Experience

JNCI : Journal of the National Cancer Institute, 2004-10, Vol.96 (20), p.1500-1509

2004

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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

Journal of clinical oncology, 2004-11, Vol.22 (22), p.4626-4631

2004

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Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

The Lancet (British edition), 2014-07, Vol.384 (9938), p.164-172

2014

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Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer

Journal of clinical oncology, 1998-01, Vol.16 (1), p.295-300

1998

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The advisory process for anticancer drug regulation: a global perspective

Annals of oncology, 2006-06, Vol.17 (6), p.889-896

2006

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Thymidylate synthase inhibitors

Clinical cancer research, 1996-02, Vol.2 (2), p.227-243

1996

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End Points and United States Food and Drug Administration Approval of Oncology Drugs

Journal of clinical oncology, 2003-04, Vol.21 (7), p.1404-1411

2003

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External control arms in oncology: current use and future directions

Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer

Optimizing Dosing of Oncology Drugs

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

The role of nonrandomized trials in the evaluation of oncology drugs

FDA Drug Approval Summary: Azacitidine (5‐azacytidine, Vidaza™) for Injectable Suspension

A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials

Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science

Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007

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

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]

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

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

Anticancer Drug Discovery and Development Throughout the World

Response Rates, Survival, and Chemotherapy Trials

Immunotherapy Combinations in Multiple Myeloma — Known Unknowns

Docetaxel

Accelerated Approval of Oncology Products: A Decade of Experience

Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer

The advisory process for anticancer drug regulation: a global perspective

Thymidylate synthase inhibitors

End Points and United States Food and Drug Administration Approval of Oncology Drugs

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