The impact of institution variability on patients outcome in a soft tissue sarcoma clinical trial

Abstract

ABSTRACT

Background: Soft-tissue sarcomas (STS) are a rare and heterogeneous group of tumors of mesenchymal origin and can start in any part of the body mainly in support and connective tissues. When performing large multicenter clinical trials, a lot of attention is paid to the standardization of the treatment procedures across the participating sites. This is done to ensure that the difference in effect observed between treatment arms, can be completely attributed to the difference in treatments. This is because heterogeneity between the participating centers may add noise to the estimation of the treatment effect. Objective: The overall objective was to investigate the impact of institution variability on patient outcome in a soft tissue sarcoma clinical trial. Specifically, to compare parameter estimates from different statistical analysis methods as well as investigate the impact of frailty misspecification on parameters of interest. Methods: In statistical analysis, semi