Mahmood Ahmad
Tahir Heart Institute
author@example.com

CT.gov Rule-Era Reporting Gap

Did ClinicalTrials.gov completion cohorts become more transparent after FDAAA 801 and the Final Rule? We analysed 249,507 older closed interventional studies from the March 29, 2026 full-registry snapshot and grouped them into four completion eras anchored to reporting-rule landmarks. For each era we estimated two-year no-results rates, ghost-protocol rates, no-publication rates, and the share with both results and publication visible. The FDAAA 801 era from 2008 to 2016 showed a 67.1 percent no-results rate, whereas the recent eligible era from 2021 to 2024 rose to 77.0 percent. Ghost protocols likewise increased from 39.6 percent in the FDAAA 801 era to 46.7 percent in the recent eligible era, while full visibility fell to 10.8 percent. Later eligible cohorts therefore do not look cleaner on these registry-visible measures even after each included study had at least two years to report. These policy-era comparisons are descriptive and do not adjudicate applicable-clinical-trial status or legal compliance within this registry frame.

Outside Notes

Type: methods
Primary estimand: 2-year no-results rate across completion eras anchored to major U.S. reporting rules
App: CT.gov Rule-Era Reporting Gap dashboard
Data: 249,507 eligible older closed interventional studies grouped into four completion eras
Code: https://github.com/mahmood726-cyber/ctgov-rule-era-reporting-gap
Version: 1.0.0
Validation: FULL REGISTRY RUN

References

1. ClinicalTrials.gov API v2. National Library of Medicine. Accessed March 29, 2026.
2. Food and Drug Administration Amendments Act of 2007, Pub L No. 110-85.
3. 42 CFR Part 11. Clinical Trials Registration and Results Information Submission. Final Rule. September 21, 2016.

AI Disclosure

This work represents a compiler-generated evidence micro-publication built from structured registry data and deterministic summary code. AI was used as a constrained coding and drafting assistant for interface generation, packaging, and prose refinement, not as an autonomous author. The analytical choices, interpretation, and final outputs were reviewed by the author, who takes responsibility for the content.