External data, referred to as data external to the traditional clinical study being planned, include but are not limited to real-world data (RWD) and data collected from clinical studies being conducted in the past or in other countries. The external data are sometimes leveraged to augment a single-arm, prospectively designed study when appropriate. In such an application, recently developed propensity score-integrated approaches including PSPP and PSCL can be used for study design and data analysis when the clinical outcomes are binary or continuous. In this paper, the propensity score-integrated Kaplan-Meier (PSKM) method is proposed for a similar situation but the outcome of interest is time-to-event. The propensity score methodology is used to select external subjects that are similar to those in the current study in terms of baseline covariates and to stratify the selected subjects from both data sources into more homogeneous strata. The stratum-specific PSKM estimators are obtained based on all subjects in the stratum with the external data being down-weighted, and then these estimators are combined to obtain an overall PSKM estimator. A simulation study is conducted to assess the performance of the PSKM method, and an illustrative example is presented to demonstrate how to implement the proposed method.
Keywords: PSKM; Survival function; external data; external evidence; propensity score; real-world data; real-world evidence; time-to-event.