Mahmood Ahmad
Tahir Heart Institute
author@example.com

Protocol: CT.gov Strict-Core Black-Box

This protocol isolates the strict U.S.-nexus drug-biological-device proxy and reads its black-box subset rather than its broader missing-results stock alone. Primary outputs compare named-sponsor black-box stock, sponsor-class black-box stock, black-box rates, and class no-results rates inside the proxy core. The aim is to identify where the deepest registry-visible silence persists inside the regulated-looking subset. Because the subset is proxy-defined, the outputs should not be read as formal ACT or FDAAA legal determinations.

Outside Notes

Type: protocol
Primary estimand: Named-sponsor and sponsor-class black-box stock inside the strict U.S.-nexus proxy core
App: CT.gov Strict-Core Black-Box dashboard
Code: https://github.com/mahmood726-cyber/ctgov-strict-core-black-box
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.