Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands

Qing Liu; Karl E. Peace

Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands

Qing Liu
, Karl E. Peace

Biostatistics, Epidemiology & Environmental Health Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

In this article, we apply this framework for moderately affected ongoing clinical trials with an integrated analysis of efficacy (IAE) approach to address unplanned protocol deviations affected by COVID-19, while still maintaining the integrity of statistical inference and interpretability of study results. It is assumed that the trial has finished patient accrual and the sample size of the original design is conservative enough that no new patients are needed.

Original language	American English
Journal	LinkedIn
State	Published - Apr 4 2020

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Disciplines

Biostatistics
Environmental Public Health
Epidemiology
Public Health

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https://www.linkedin.com/pulse/statistical-considerations-clinical-trials-during-iae-asa-fellow/

Cite this

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title = "Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands",

abstract = " In this article, we apply this framework for moderately affected ongoing clinical trials with an integrated analysis of efficacy (IAE) approach to address unplanned protocol deviations affected by COVID-19, while still maintaining the integrity of statistical inference and interpretability of study results. It is assumed that the trial has finished patient accrual and the sample size of the original design is conservative enough that no new patients are needed.",

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T1 - Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands

AU - Liu, Qing

AU - Peace, Karl E.

PY - 2020/4/4

Y1 - 2020/4/4

N2 - In this article, we apply this framework for moderately affected ongoing clinical trials with an integrated analysis of efficacy (IAE) approach to address unplanned protocol deviations affected by COVID-19, while still maintaining the integrity of statistical inference and interpretability of study results. It is assumed that the trial has finished patient accrual and the sample size of the original design is conservative enough that no new patients are needed.

AB - In this article, we apply this framework for moderately affected ongoing clinical trials with an integrated analysis of efficacy (IAE) approach to address unplanned protocol deviations affected by COVID-19, while still maintaining the integrity of statistical inference and interpretability of study results. It is assumed that the trial has finished patient accrual and the sample size of the original design is conservative enough that no new patients are needed.

UR - https://digitalcommons.georgiasouthern.edu/bee-facpubs/151

UR - https://www.linkedin.com/pulse/statistical-considerations-clinical-trials-during-iae-asa-fellow/

M3 - Article

JO - LinkedIn

JF - LinkedIn

ER -

Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands

Abstract

UN SDGs

Disciplines

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