The Guardian Research Network: A Real-World Data Source for Pharmacoepidemiologic Research and Regulatory Applications.

ABSTRACT:

Background

The quality of real-world data (RWD) directly impacts the value of real-world evidence (RWE) generated for regulatory decision-making. Data owners and investigators must be prepared to provide documentation on data quality assessments to regulators when submitting secondary data for regulatory purposes. While robust feasibility is required to justify the relevance of a data source for a specific research question, the reliability of the data, including the chain of custody and data journey prior to reaching the end user, is of equal importance for drawing valid, meaningful conclusions.

Aims

Recently, Castellanos et al. constructed a definition of RWD quality by synthesizing definitions across published guidelines to characterize quality attributes of Flatiron Heal

SUBMITTER: McCracken A 

PROVIDER: S-EPMC12417101 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature