Clinical Trial Results Reporting Compliance Under FDAAA

A 2011 cross-sectional study examined compliance with mandatory results reporting on ClinicalTrials.gov for trials completing in 2009. The analysis identified 738 trials subject to the Food and Drug Administration Amendments Act (FDAAA) rules, finding only 22% reported results within the required one-year timeframe. The study also compared reporting rates for trials not subject to mandatory rules and analyzed factors like trial phase and funding source.

Use Cases

• Analyze the association between trial phase and the likelihood of results reporting using the study's statistical findings (P=4.4x10^-11).
• Compare results reporting rates between industry-funded and non-industry-funded trials based on the reported significance (P=2.2x10^-16).
• Examine the difference in reporting proportions between FDAAA-covered trials (22%) and non-covered trials (10%) using the provided confidence interval (7.8% to 15.5%).
• Study the criteria for mandatory reporting under FDAAA, including trial type (drug/device/biological), presence of a US site, and phase (II or later).

Strengths

• Analysis is based on a specific snapshot of 83,579 interventional trials from the ClinicalTrials.gov registry.
• The study applies clear selection criteria, focusing on 5,642 trials completed within the defined 2009 timeframe.
• Statistical significance for key findings (e.g., funding source impact) is provided with precise p-values.

Limitations

• The underlying registry data is from a single point in time (January 19, 2011) and is now over a decade old.
• The study's core analysis focuses on a specific one-year cohort (trials completed in 2009), limiting longitudinal analysis.
• The dataset is derived from a published study's analysis, not the raw ClinicalTrials.gov data, limiting direct re-analysis.

Provenance

Source

ClinicalTrials.gov registry, cross-referenced with Drugs@FDA.

Collection Method

Registry-based cross-sectional study with defined search and selection criteria.

Time Range

Trials completed between January 1 and December 31, 2009, with registry data extracted on January 19, 2011.

Freshness

The dataset metadata was last updated in 2019, but the underlying study and data are from 2011.

Geography

Trials with at least one US site.