Constructing a finer-grained representation of clinical trial results from ClinicalTrials.gov

Abstract

Randomized controlled trials are essential for evaluating clinical interventions; however, selective reporting and publication bias in medical journals have undermined the integrity of the clinical evidence system. ClinicalTrials.gov serves as a valuable and complementary repository, yet synthesizing information from it remains challenging. This study introduces a curated dataset that extends beyond the traditional PICO framework. It links efficacy with safety results at the experimental arm group level within each trial, and connects them across all trials through a knowledge graph. This novel representation effectively bridges the gap between generally described searchable information and specifically detailed yet underutilized reported results, and promotes a dual-faceted understanding of interventional effects. Adhering to the “calculate once, use many times” principle, the structured dataset will enhance the reuse and interpretation of ClinicalTrials.gov results data. It aims to facilitate more systematic evidence synthesis and health technology assessment, by incorporating both positive and negative results, distinguishing biomarkers, patient-reported outcomes, and clinical endpoints, while also balancing both efficacy and safety outcomes for a given medical intervention.