Real-World Evidence Prediction of a Phase IV Oncology Trial: Comparative Degarelix vs Leuprolide Safety.

ABSTRACT:

Background

Medical and regulatory communities are increasingly interested in the utility of real-world evidence (RWE) for answering questions pertaining to drug safety and effectiveness but concerns about validity remain. A principled approach to conducting RWE studies may alleviate concerns and increase confidence in findings. This study sought to predict the findings from the PRONOUNCE trial using a principled approach to generating RWE.

Methods

This propensity-score (PS) matched observational cohort study utilized 3 claims databases to compare the occurrence of major adverse cardiovascular events (MACE) among initiators of degarelix vs. leuprolide. Patients were included if they had history of prostate cancer and atherosclerotic cardiovascular disease. Subjects were exclu

SUBMITTER: Merola D 

PROVIDER: S-EPMC9403105 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature