FDAAA TrialsTracker: Monitoring Compliance with Clinical Trials Reporting

Non-publication of clinical trial results is a significant concern in the medical community, as it impacts the transparency and reliability of healthcare data. To address this ongoing issue, researchers from the EBM DataLab at the University of Oxford have developed the FDAAA TrialsTracker. This online tool aims to improve compliance with the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007, which mandates that clinical trial results must be reported to ClinicalTrials.gov. Explore how the FDAAA TrialsTracker operates, its key features, and how it aims to enhance accountability in clinical research.

What is FDAAA TrialsTracker?

The FDAAA TrialsTracker is a live informatics tool designed to monitor compliance with clinical trial reporting requirements set forth by the FDAAA 2007. It provides a public platform that allows users to see which clinical trials have not reported their results, encouraging greater transparency and accountability. By analyzing data from ClinicalTrials.gov, the tool identifies trials required to publish results and tracks whether they are compliant with the updated regulations.

Key Features of FDAAA TrialsTracker

1. Real-Time Compliance Tracking: The tool monitors the compliance of clinical trials in real-time, providing an overview of which trials have fulfilled their obligation to report results and which have not. It aims to facilitate public audits and hold sponsors accountable for non-compliance.
2. Identification of Due Trials: FDAAA TrialsTracker automatically determines which trials are due to report results based on key dates, such as the primary completion date. This information is obtained from publicly available data on ClinicalTrials.gov, ensuring that users can access up-to-date information.
3. Public Accountability and Transparency: The tool is an essential instrument for encouraging compliance by highlighting gaps in trial reporting. It makes it easy for sponsors and the public to identify unreported trials. This transparency helps improve performance and ensures that healthcare professionals and patients have access to critical trial results.

Methods Behind FDAAA TrialsTracker

The FDAAA TrialsTracker was developed by reviewing the relevant statutes and identifying the exact requirements for clinical trial reporting under FDAAA 2007. Specific sections of the legislation were converted into algorithms, and the resulting code operationalizes the process of identifying non-compliant trials. The tool also utilizes BigQuery and Python for data processing and analysis, making the system both robust and adaptable for future updates.

Challenges in Implementation

Developing the FDAAA TrialsTracker faced several challenges, including:

• Data Availability: Not all the data elements needed for determining a trial’s compliance are made public by ClinicalTrials.gov. This required a conservative approach to identifying non-compliance, ensuring only accurate and well-supported assessments were made.
• Legislation Gaps: The initial reporting requirements were vague, and further clarifications were needed under the Final Rule of 2016. This led to difficulties in categorizing some clinical trials as compliant or non-compliant, especially for trials involving Investigational New Drug (IND) and Investigational Device Exemption (IDE) statuses, which are not available in the public dataset.

Results: Encouraging Compliance

Since its launch in February 2018, the FDAAA TrialsTracker has successfully provided public insight into the compliance of clinical trials. It displays an up-to-date overview of all relevant clinical trials, categorized by their compliance status. The tool has encouraged numerous sponsors to take action to report overdue trials, contributing to the broader movement towards transparent and responsible research practices.

1. Compliance Rates: Despite guidelines and regulations, a large number of clinical trials still fail to report their results on time. The FDAAA TrialsTracker shows which sponsors are performing well and which are lagging, promoting a culture of openness and accountability.
2. Potential Penalties: The tool also calculates the potential fines that could have been imposed on non-compliant sponsors based on FDA guidelines, highlighting the consequences of failing to report trial results.

Applications of FDAAA TrialsTracker

1. Improving Research Quality: The FDAAA TrialsTracker helps raise the standard of clinical research by promoting the publication of trial results. By making the data publicly accessible, it provides patients, healthcare providers, and researchers with complete information about clinical studies, improving treatment outcomes.
2. Sponsor-Level Performance: Sponsors can use the tool to monitor their trials and ensure that all their studies meet compliance standards. It also gives a public platform to identify sponsors who are not fulfilling their legal obligations, encouraging better performance across the industry.

The FDAAA TrialsTracker is a crucial tool for improving transparency and accountability in clinical trials. By providing live, accessible data on trial compliance, the tool is helping to bridge the gap in unreported research, thereby supporting the ethical obligation to disclose all clinical trial results. It is an example of how open data and technology can be leveraged to ensure better research practices, benefiting both the medical community and patients.