Mahmood Ahmad
Tahir Heart Institute
author@example.com

Protocol: CT.gov Probable ACT/FDAAA Debt

This protocol creates conservative U.S.-nexus proxy layers inside eligible older closed interventional ClinicalTrials.gov studies. The layers use recorded U.S. locations, intervention families, and a phase exclusion to approximate a broad nexus layer, a drug-or-biological non-phase1 layer, and a stricter drug-biological-device U.S. layer. Primary outputs compare no-results rates, ghost-protocol rates, visible-share rates, overdue years, sponsor-class composition, and completion-era gradients inside each proxy layer. The aim is to estimate the scale and age of likely regulated reporting debt without claiming a formal legal ACT or FDAAA determination.

Outside Notes

Type: protocol
Primary estimand: Missing-results rate and overdue debt within conservative U.S.-nexus ACT-style proxy layers
App: CT.gov Probable ACT/FDAAA Debt dashboard
Code: https://github.com/mahmood726-cyber/ctgov-probable-act-fdaaa-debt
Date: 2026-03-29
Validation: FULL REGISTRY RUN

References

1. ClinicalTrials.gov API v2. National Library of Medicine. Accessed March 29, 2026.
2. DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet. 2020;395(10221):361-369.
3. Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov. N Engl J Med. 2016;375(20):1998-2004.

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.