factually
Index/Topics/Clinical Study Reports and Individual Participant Data

Clinical Study Reports and Individual Participant Data

The differences and complementary nature of clinical study reports and individual participant data in clinical trials and their impact on regulatory conclusions and independent reanalysis.

Fact-Checks

1 result
Feb 6, 2026

How do clinical study reports published by regulators differ from raw individual participant‑level datasets, and why does that matter for independent reanalysis?

and regulator summaries are curated, document-level narratives and aggregated analyses of trials, while individual participant data (IPD) are the raw, participant‑level records that underlie those sum...