Treatment effect estimation using the propensity score in clinical trials with historical control.

ABSTRACT:

Background

Clinical trials assessing new treatment effects require a control group to compare the pure treatment effects. However, in clinical trials on regenerative medicine, rare diseases, and intractable diseases, it may be ethically difficult to assign participants to the control group. In recent years, the use of historical control data has attracted attention as a method for supplementing the number of participants in the control group. When combining historical control data with new randomized controlled trial (RCT) data, the assessment of heterogeneity using outcome data is not sufficient. Therefore, several statistical methods that consider participant outcomes and baseline characteristics, including the propensity score (PS) method have been proposed.

Methods

We pr

SUBMITTER: Kanamori S 

PROVIDER: S-EPMC10882803 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature