Journal
STATISTICS IN BIOPHARMACEUTICAL RESEARCH
Volume 12, Issue 2, Pages 155-163Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/19466315.2019.1647873
Keywords
Estimand; Nonrandomized study; Propensity score; Real-world data; Two-stage design
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Nonrandomized comparative studies have been widely proposed and conducted in the premarket safety and effectiveness evaluation of medical devices. A typical case is to compare results of a clinical study on an investigational device with those of control, which is formed based on prior studies or some real-world data. Propensity score methodology is often used to mitigate the bias caused by the imbalance of the patient baseline characteristics. To maintain the objectivity of study design and validity of study results, proper procedure of two-stage design needs to be implemented. In this article, considerations of the analysis elements of such studies, such as endpoint analysis, missing data handling, and subgroup analysis, are discussed. An example is provided to illustrate these considerations.
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