Systematic data capture reduces the need for source data verification: exploratory analysis from a phase 2 multicenter randomized controlled platform trial.

ABSTRACT:

Background

The COVID-19 pandemic gave rise to clinical trials focused on systematic, accurate primary data capture, and reduced reliance on source data verification (SDV). Here, we report on a natural experiment that allowed us to assess the quality, cost, and impact of this approach compared to traditional SDV.

Methods

The I-SPY COVID trial (NCT04488081) was a multicenter, open-label, platform trial that employed a streamlined daily checklist, daily capture of labs and medications, and centralized monitoring to ensure accurate data collection in lieu of SDV. The trial enrolled 1,111 patients in 11 drug arms with severe COVID-19. After the trial arms were closed, extensive retrospective SDV was performed on 333 (30.0%) patients, including 10,101 of 44,486 (23%) electronic ca

SUBMITTER: Abbasi AB 

PROVIDER: S-EPMC12572212 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature