The Importance of Clinical Trial Disclosure

Transparency in clinical trials is critical. Without disclosure, patients lose trust, scientific progress stalls, and key data that could improve outcomes for large groups is left unshared. Yet many trials fail to report results. In fact, research published in the New England Journal of Medicine found that many trials on ClinicalTrials.gov fail to report their findings—with less than 14% reporting within a year and fewer than 39% reporting at all over the course of five years.

For pharmaceutical and biotech companies, clinical trial disclosure is especially complex. Whether you’re a large organization managing global regulations or a smaller team with limited resources, staying compliant can feel overwhelming. Let’s break down what trial disclosure involves, why it’s important, and how the right talent can help ensure compliance.

What Is Clinical Trial Disclosure?

Clinical trial disclosure involves sharing information about clinical studies to ensure transparency and compliance with global laws. In the U.S., the FDA Amendments Act (FDAAA) mandates that study details and results be registered with ClinicalTrials.gov. In the EU, Directive 2001/20/EC requires similar disclosures on EudraCT, including additional rules for pediatric trials. Beyond these, countries worldwide have their own standards.

Key questions to consider

• Do you understand the specific disclosure requirements for every country involved in your global study?
• Is your organization fully compliant with these regulations?

Clinical Trial Registration: The Foundation of Compliance

In the U.S., FDAAA requires that study protocols—including study design, oversight, outcome measures, and eligibility criteria—be submitted within 21 days of the study start date. This data must be maintained throughout the trial, incorporating updates like protocol amendments or site status changes.

Key questions to consider

• Do you have a system to alert your disclosure team when an amendment is finalized?
• How do you track site status changes to ensure accurate updates?

Clinical Trial Results Disclosure: The Next Challenge

Results disclosure under FDAAA requires submitting detailed scientific data tables covering participant flow, baseline characteristics, outcome measures, statistical analyses, and adverse events. For studies with a primary completion date after January 18, 2017, additional documentation like study protocols and statistical analysis plans is required.

Key questions to consider

• Are you aware that secondary outcomes must be disclosed within 12 months of their completion, even if the study itself isn’t finished?
• Do you know that pediatric study deadlines differ globally, often requiring results within 6 months?

Why Does Disclosure Matter?

Transparency in clinical trials builds trust and accountability. It’s also a legal requirement, as noncompliance can lead to daily fines and public notices. For patients and the public, it reassures them that the research process is ethical and open.

The Challenges of Compliance

Compliance isn’t easy, especially for smaller pharmaceutical companies where employees often wear many hats. For larger organizations, managing data across global teams can result in delays or errors. There’s also the fear that sharing trial information could reveal proprietary methods to competitors.

Key Roles in Clinical Trial Disclosure

Compliance requires collaboration across multiple functions, including the roles listed below. Each role plays a critical part in ensuring accurate and timely disclosure.

• Protocol Authors
• Clinical Scientists
• Study Managers
• Statistical Analysts
• Medical Writers
• Project Managers
• Legal and Regulatory Teams

Unique Challenges in the EU

The EU’s requirements, particularly for pediatric studies, add layers of complexity. Even U.S.-based studies tied to a Pediatric Investigation Plan (PIP) may require submission to EudraCT. Frequent website updates and varying national laws make it even harder for smaller companies to keep up without a dedicated team.

The Future Role of AI in Clinical Trial Disclosure

Artificial intelligence could transform this process by automating repetitive tasks like drafting results or creating patient summaries. However, human oversight will always be essential to ensure accuracy and compliance.

How the Right Partner Can Ease the Burden of Compliance

Smaller companies might benefit from on-demand services for managing registrations and results, avoiding the cost of full-time staff for a task that’s not constant. Larger organizations may prefer to fully outsource their disclosure operations, ensuring consistency and compliance without straining internal resources.

At the end of the day, the right staffing model—whether it’s part-time consultants, full-service outsourcing, or project-based support—can help companies navigate the challenges of clinical trial disclosure while staying focused on their core work.

If you're ready to partner with experts who can ensure compliance with clinical trial disclosure, don't hesitate to reach out to us here!