The Anatomy of Hiddenness: A Multi-Axis Audit of Structural Non-Disclosure in ClinicalTrials.gov

Authors

  • Andrew Woo
    Competing Interests
    None declared.

Abstract

Systematic reviews increasingly use ClinicalTrials.gov as a core source for registered trials, but the completeness and linkage quality of the registry record are rarely incorporated formally into synthesis. A large number of registered studies never post results and never link to a publication. Using a single 29 March 2026 full-registry snapshot — 578,109 records, of which 441,191 were interventional and 290,524 were closed interventional — we used 249,507 eligible older closed interventional studies as the analytic core and audited structural non-disclosure along six axes. Two-year no-results rates ran from 67.0% in oncology to 76.2% in metabolic medicine. The missingness is structured: it tracks phase, architecture (one-arm 72.8% vs >=10-arm 55.3%), and outcome density (100% no-results when zero primary outcomes are recorded). Geographic footprint matters (single-site 79.5% vs >=20-site 31.7%), as does completion speed (same-year 85.7% vs 6-10-year lag 57.6%). Missingness is concentrated - the top 1% of lead sponsors hold 39.6% of the backlog (Gini 0.818). A strict NCT-indexed PubMed audit rescued only 1.2% of no-link studies; broadening to Europe PMC lifted weighted NCT-visible external-trace matching to 40.8%, indicating that a large fraction of apparent registry silence is an indexing-and-linkage gap rather than true absence. Hiddenness is a predictable, measurable property of the registry, and should be priced into downstream synthesis.
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Published

2026-06-24 — Updated on 2026-06-25

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Research Article

How to Cite

The Anatomy of Hiddenness: A Multi-Axis Audit of Structural Non-Disclosure in ClinicalTrials.gov. (2026). Synthesis, 2(7). https://synthesis-medicine.org/index.php/journal/article/view/172 (Original work published 2026)

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