Mahmood Ahmad
Tahir Heart Institute
author@example.com

Protocol: CT.gov Rule-Era Reporting Gap

This protocol groups eligible older closed interventional ClinicalTrials.gov studies into completion eras aligned to major U.S. registry-reporting milestones. Primary outputs compare two-year no-results rates, ghost-protocol rates, no-publication rates, and full-visibility shares across pre-FDAAA, FDAAA, and later eras. The aim is to test whether later eligible cohorts look cleaner on registry-visible measures after rule changes. These comparisons remain descriptive because the project does not adjudicate applicable-clinical-trial status or legal exposure study by study.

Outside Notes

Type: protocol
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
Code: https://github.com/mahmood726-cyber/ctgov-rule-era-reporting-gap
Date: 2026-03-29
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.