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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Clinical cancer research, 2013-09, Vol.19 (17), p.4559-4563

2013

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Issues in Using Progression-Free Survival When Evaluating Oncology Products

Journal of clinical oncology, 2009-06, Vol.27 (17), p.2874-2880

2009

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Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek

Clinical trials (London, England), 2023-08, Vol.20 (4), p.341-350

2023

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U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

The oncologist (Dayton, Ohio), 2014-01, Vol.19 (1), p.94-99

2014

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U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

Clinical cancer research, 2012-06, Vol.18 (12), p.3212-3217

2012

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Design and Analysis of Non-Inferiority Trials

1, 2016

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U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Clinical cancer research, 2010-09, Vol.16 (17), p.4331-4338

2010

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Some essential considerations in the design and conduct of non-inferiority trials

Clinical trials (London, England), 2011-08, Vol.8 (4), p.432-439

2011

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Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

Therapeutic innovation & regulatory science, 2023-01, Vol.57 (1), p.109-120

2023

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Design and analysis of non-inferiority mortality trials in oncology

Statistics in medicine, 2003-01, Vol.22 (2), p.239-264

2003

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Approval Summary for Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia

Clinical cancer research, 2002-05, Vol.8 (5), p.935-942

2002

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U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens

Clinical cancer research, 2008-03, Vol.14 (5), p.1296-1302

2008

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U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

The oncologist (Dayton, Ohio), 2011-01, Vol.16 (1), p.97-104

2011

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Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer

Clinical cancer research, 2008-06, Vol.14 (11), p.3242-3247

2008

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Perspectives on informative Bayesian methods in pediatrics

Journal of biopharmaceutical statistics, 2023-11, Vol.33 (6), p.830-843

2023

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14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (afternoon panel discussion)

Clinical trials (London, England), 2023-08, Vol.20 (4), p.405-415

2023

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Resampling‐based stepwise multiple testing procedures with applications to clinical trial data

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-03, Vol.20 (2), p.297-313

2021

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Inferences on a life distribution by sampling from the ages or the ages at death

Lifetime data analysis, 2006-09, Vol.12 (3), p.305-323

Rothmann, Mark D

2006

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Bayesian Hierarchical Models for Subgroup Analysis

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2024-07

2024

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Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials

Journal of biopharmaceutical statistics, 2023-03, Vol.33 (2), p.234-252

2023

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Should responder analyses be conducted on continuous outcomes?

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-03, Vol.22 (2), p.312-327

2023

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Missing Data in Biologic Oncology Products

Journal of biopharmaceutical statistics, 2009-11, Vol.19 (6), p.1074-1084

2009

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Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Panel discussion on considerations in design and analysis

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-09, Vol.20 (5), p.952-964

2021

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Approval summary: Imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors

Clinical cancer research, 2002-10, Vol.8 (10), p.3034-3038

2002

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Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER

Therapeutic innovation & regulatory science, 2023-05, Vol.57 (3), p.436-444

2023

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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Issues in Using Progression-Free Survival When Evaluating Oncology Products

Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek

U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

Design and Analysis of Non-Inferiority Trials

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Some essential considerations in the design and conduct of non-inferiority trials

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

Design and analysis of non-inferiority mortality trials in oncology

Approval Summary for Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia

U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens

U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer

Perspectives on informative Bayesian methods in pediatrics

14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (afternoon panel discussion)

Resampling‐based stepwise multiple testing procedures with applications to clinical trial data

Inferences on a life distribution by sampling from the ages or the ages at death

Bayesian Hierarchical Models for Subgroup Analysis

Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials

Should responder analyses be conducted on continuous outcomes?

Missing Data in Biologic Oncology Products

Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Panel discussion on considerations in design and analysis

Approval summary: Imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors

Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER

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