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

Table 1 Sample size in each PS stratum.

Table 2 Overlapping coefficient, standardized overlapping coefficient, nominal number of patients to be borrowed, and power parameter (or weight) in each stratum.

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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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Table 1 Sample size in each PS stratum.

Table 2 Overlapping coefficient, standardized overlapping coefficient, nominal number of patients to be borrowed, and power parameter (or weight) in each stratum.

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