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Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics

Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches

Heng Lia Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Wei-Chen Chena Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Nelson Lua Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Changhong Songa Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Chenguang Wangb Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD

https://orcid.org/0000-0002-7085-3303

Ram Tiwaria Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Yunling Xua Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD;

Lilly Q. Yuea Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD; Correspondence[email protected]

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Freda Cooner, Toshimitsu Hamasaki, Frank Bretz, Gene Pennello & Martin Posch. (2022) Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics. Statistics in Biopharmaceutical Research 14:1, pages 1-2.
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Articles from other publishers (2)

Bradley P Carlin & Fabrice Nollevaux. (2022) Bayesian Complex Innovative Trial Designs (CIDs) and Their Use in Drug Development for Rare Disease. The Journal of Clinical Pharmacology 62:S2.
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Arnaud Monseur, Bradley P. Carlin, Bruno Boulanger, Andreea Seferian, Laurent Servais, Chris Freitag, Leen Thielemans, Teresa Gidaro, Elena Gargaun, Virginie Chê, Ulrike Schara, Andrea Gangfuß, Adele D’Amico, James J. Dowling, Basil T. Darras, Aurore Daron, Arturo Hernandez, Capucine de Lattre, Jean-Michel Arnal, Michèle Mayer, Jean-Marie Cuisset, Carole Vuillerot, Stéphanie Fontaine, Rémi Bellance, Valérie Biancalana, Ana Buj-Bello, Jean-Yves Hogrel, Hal Landy, Kimberly Amburgey, Barbara Andres, Enrico Bertini, Ruxandra Cardas, Séverine Denis, Dominique Duchêne, Virginie Latournerie, Nacera Reguiba, Etsuko Tsuchiya & Carina Wallgren-Pettersson. (2021) Leveraging Natural History Data in One- and Two-Arm Hierarchical Bayesian Studies of Rare Disease Progression. Statistics in Biosciences 14:2, pages 237-258.
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Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches

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Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches

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