Propensity score-based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation.

Abstract

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 to facilitate causal inference for treatment effects. The methodology had been used mainly in epidemiological and social science studies that may often be exploratory, until it was adopted by FDA/CDRH in 2002 and applied in the evaluation of medical device pre-market confirmatory studies, including those with a control group