Propensity score analysis is a versatile statistical method used mainly in observational
studies for improving treatment comparison by adjusting for up to a relatively large number …

In this short note, we highlight some key elements of the process of submitting an
investigational device exemption of a nonrandomized clinical study that involves the use of …

In the evaluation of medical products, including drugs, biological products, and medical
devices, comparative observational studies could play an important role when properly …

Randomized clinical trials (RCT) are accepted as the gold-standard approaches to measure
effects of intervention or treatment on outcomes. They are also the designs of choice for …

Real‐time data collection of patient health status and medications is sped up with modern
electronic devices and technologies. As real‐world data provide enormous research …

Nonrandomized comparative studies have been widely proposed and conducted in the
premarket safety and effectiveness evaluation of medical devices. A typical case is to …

The breakthrough propensity score methodology was formulated by Rosenbaum and Rubin
in the 1980s for the mitigation of confounding bias in non‐randomized comparative studies …

In recent years, with the rapid increase in the volume and accessibility of Real-World-Data
(RWD) and Real-World-Evidence (RWE), we have seen the unprecedented opportunities for …

Purpose To document which established criteria for logistic regression modeling
researchers consider when using propensity scores in observational studies. Methods We …

The propensity score is defined to be a subject's probability of treatment selection,
conditional on observed baseline covariates. Conditional on the propensity score, treated …