Statistical Considerations for Clinical Trials During COVID-19: Natural History Controls for Survival Analysis (Part I)

Document Type

Article

Publication Date

4-8-2020

Publication Title

LinkedIn

Abstract

To address this general difficulty, as well as various difficulties specific to impacts of COVID-19, we describe the approach of using natural history studies for comparative effectiveness analysis used in rare disease drug approval applications. This article is divided in three parts: substantial evidence standards, virtual matched control methodology, and inappropriateness of existing methods such as propensity score methods.

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