Publications by authors named "Thomas Gwise"

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Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials.
Philip He, Haijun Ma, Chengxing Cindy Lu, Revathi Ananthakrishnan, Gu Mi, Thomas Gwise

Ther Innov Regul Sci· November 2025

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Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials.
Bindu Kanapuru, Laura L Fernandes, Andrea Baines, Rachel Ershler, Vishal Bhatnagar, Thomas Gwise

Blood· July 2023

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FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity.
Dianne Pulte, Laura Fernandes, Guo Wei, Ashley Woods, Kelly J Norsworthy, Thomas E Gwise

Clin Lymphoma Myeloma Leuk· June 2023

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Extreme body mass index and survival in newly diagnosed multiple myeloma patients.
Urvi A Shah, Karissa Whiting, Sean Devlin, Rachel Ershler, Bindu Kanapuru, Thomas Gwise

Blood Cancer J· January 2023

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Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients.
Jeanne Fourie Zirkelbach, Mirat Shah, Jonathon Vallejo, Joyce Cheng, Amal Ayyoub, Thomas Gwise

J Clin Oncol· October 2022

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Exploring racial disparities in treatment patterns and outcomes for patients with multiple myeloma using real world data.
Kathleen Maignan, Lola A Fashoyin-Aje, Aracelis Z Torres, Laura L Fernandes, Thomas Gwise

Blood Cancer J· April 2022

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Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses.
Kelly J Norsworthy, Xin Gao, Chia-Wen Ko, E Dianne Pulte, Jiaxi Zhou, Thomas E Gwise

J Clin Oncol· March 2022

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Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials.
Bindu Kanapuru, Laura L Fernandes, Lola A Fashoyin-Aje, Andrea C Baines, Vishal Bhatnagar, Thomas Gwise

Blood Adv· March 2022

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Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement.
Laura L Fernandes, Jiaxi Zhou, Bindu Kanapuru, Erica Horodniceanu, Thomas Gwise

Blood Cancer J· August 2021

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FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease.
Bellinda L King-Kallimanis, Tanya Wroblewski, Virginia Kwitkowski, R Angelo De Claro, Thomas Gwise

Qual Life Res· July 2020

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FDA's Approval of the First Biosimilar to Bevacizumab.
Sandra J Casak, Steven J Lemery, Jee Chung, Chana Fuchs, Sarah J Schrieber, Thomas Gwise

Clin Cancer Res· September 2018

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Determination of Similarity Margin in Comparative Clinical Studies to Support the Development of Biosimilar Products of Neupogen (Filgrastim, Granulocyte Colony-Stimulating Factor [G-CSF]).
Lei Nie, Donna Przepiorka, Albert Deisseroth, Rajeshwari Sridhara, Thomas E Gwise

BioDrugs· August 2018

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Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.
Kun He, Huanyu Chen, Thomas Gwise, Sandra Casak, Steven Lemery

Clin Cancer Res· November 2016

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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Geoffrey Kim, Gwynn Ison, Amy E McKee, Hui Zhang, Shenghui Tang, Thomas Gwise

Clin Cancer Res· October 2015

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Evaluation of heart failure biomarker tests: a survey of statistical considerations.
Arkendra De, Kristen Meier, Rong Tang, Meijuan Li, Thomas Gwise

J Cardiovasc Transl Res· August 2013

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