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Examining characteristics of compliant clinical trials: results reporting pre & post punctuated regulatory rulings exploring transparency & accountability in clinical trials
Dissertation   Open access

Examining characteristics of compliant clinical trials: results reporting pre & post punctuated regulatory rulings exploring transparency & accountability in clinical trials

Jeanie Magdalena Gatewood
Doctor of Business Administration (D.B.A.), Drexel University
Feb 2026
DOI:
https://doi.org/10.17918/00011274
pdf
Gatewood_Jeanie_20262.61 MBDownloadView
PDFOpen Access (License Unspecified),  Open Access

Abstract

Animal sciences Artificial intelligence integrity Clinical research ClinicalTrials.gov Legitimacy theory Results reporting Trial transparency
Timely clinical trial result reporting ensures scientific integrity, ethical accountability, biomedical regulatory oversight, and public trust -- as a critical component in bringing reliable and safe therapies to market. Although the U.S. Food and Drug Administration Amendments Act, Section 801 (FDAAA 801) (U.S. Food and Drug Administration, 2007), the Final Rule (U.S. Food and Drug Administration, 2017) and judicial rulings such as Seife and Lurie v. U.S. Department of Health and Human Services (United States District Court for the Southern District of New York, 2020) were designed to strengthen results-reporting obligations, a substantial proportion of trials fail to report primary endpoint data within the required 12-month window. Persistent non-compliance raises concerns about effectiveness of federal oversight and institutional forces shaping sponsor behavior. This dissertation applies an expanded Legitimacy Theory framework to examine structural drivers of on-time results reporting. Using a quantitative, multivariate predictive design, this study integrates three major publicly available data sources--ClinicalTrials.gov, TrialsTracker.net, CMS ICD-10 Codes--to construct one of the largest analyses of reporting behavior to date (N ~ 147,000 interventional trials; N ~ 104,000 non-exempt trials spanning 2007 to 2024). Key variables include trial phase, funder type, therapeutic area, geographic location, and regulatory epoch. A main-effects logistic regression model evaluates how institutional legitimacy and structural characteristics influence compliance. On-time reporting remains extremely low across the clinical research landscape. Across regulatory epochs, reporting declined rather than improved: 4.9% (2007-2016), 4.8% (2017-2019), and 2.0% (2020-2024), despite heightened policy and judicial rulings. Instead, disclosure is driven primarily by trial characteristics: later-phase studies outperform early-phase trials. Across epochs, later-phase trials consistently outperform early-phase trials (5.3% vs. 4.2%; 4.8% vs. 4.0%; and 2.1% vs. 1.8%, respectively). NIH-funded (9.2%) and independent investigators (5.5%) report more frequently than industry (3.6%) and academia (2.7%). U.S.-based trials reported at substantially higher rates than non-U.S. trials across all epochs (8.0%, 9.0%, 4.9% vs. 3.5%, 3.2%, 1.1%). Therapeutic area, however, does not independently influence reporting once structural factors are controlled. Notably, oncology--representing over half of trials--declined in relative reporting rank across 26 disease categories (2nd, 14th, and 21st across successive epochs. These findings advance legitimacy-based insights of regulatory compliance and identify structural levers for improving transparency. They provide an empirical foundation and contribute to discourse emphasizing strengthened enforcement alignment, harmonized global expectations, and integration of reporting obligations into operational and funding workflows--essential to restore credibility in clinical research.

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