Basic Results and Trial Disclosure Reporting: Transparency in Action

By ‘Femi Fajimi | 30 April 2025

As I continue developing as a regulatory medical writer, one key area that stands out is the importance of trial transparency. Clinical research does not end when a study closes; it extends to how results are reported and shared publicly.

Basic results reporting and trial disclosure ensure that trial data, whether positive, negative, or inconclusive, are made accessible to the public, fulfilling regulatory, ethical, and scientific obligations.

Learning about this process has helped me appreciate how crucial transparent reporting is in protecting public trust, supporting evidence-based healthcare, and honouring participant contributions.

What Is Basic Results Reporting?

Basic results reporting involves submitting a structured summary of a trial’s outcomes to a recognised public registry.

Typical registries include ClinicalTrials.gov, the EU Clinical Trials Register, and others accepted globally.

The essential components reported usually include:

• Participant flow (enrolment, completion, withdrawal, reasons for discontinuation)
• Baseline characteristics (e.g., age range, gender distribution, disease status)
• Primary and secondary outcome results (what the study measured and found)
• Serious and non-serious adverse events (number, nature, severity)

These entries must meet specific content, formatting, and timeline requirements, typically within 12 months of the trial’s completion.

Why Is Results Disclosure Important?

Disclosure obligations arise under major frameworks like:

• FDAAA 801 (Food and Drug Administration Amendments Act) in the United States
• EU Clinical Trials Regulation 536/2014
• WHO Joint Statement on Public Disclosure of Results

Timely results reporting ensures that:

• Findings from all studies, not just successful ones, are accessible
• Selective reporting or publication bias is reduced
• Healthcare providers, patients, and researchers have a fuller evidence base for decision-making
• Sponsors fulfil ethical obligations to participants and the broader public

The Role of the Regulatory Writer

As a developing writer, I am learning that regulatory writers play an active role in supporting results disclosure, including:

• Reviewing Clinical Study Reports (CSRs) and protocols to cross-check data before submission
• Preparing or helping format structured data tables for registries
• Ensuring accuracy, clarity, and non-promotional presentation of results
• Understanding registry-specific formats and expectations (e.g., ClinicalTrials.gov templates vs EU CTR fields)
• Supporting compliance with submission timelines to avoid regulatory penalties

Writers must ensure that every entry:

Reflects the protocol-defined endpoints

Matches the final statistical analysis without introducing bias

Reports adverse events clearly, including frequency and severity

Maintains neutral, factual language throughout

Key Skills I Am Building

Through studying results disclosure and basic reporting, I am developing:

• A stronger focus on data accuracy and regulatory consistency
• Practical knowledge of registry platforms (ClinicalTrials.gov, EU CTR)
• Understanding of structured data entry formats
• Familiarity with regulatory timelines and compliance tracking
• Awareness of ethical principles underpinning research transparency

➡️ View Sample

BASIC RESULTS TABLE – Educational Purpose Only

References

• U.S. National Institutes of Health. ClinicalTrials.gov Results Data Element Definitions. 2022.
• European Medicines Agency. Clinical Trials Regulation (EU No. 536/2014).
• WHO. Joint Statement on Public Disclosure of Results from Clinical Trials. 2017.
• TranspariMED. Clinical Trial Reporting Requirements in the EU. 2021.
• Health Research Authority (UK). Research Transparency Strategy 2020–2025.

⚠️ Disclaimer

This post and accompanying sample were developed for educational and illustrative purposes only.

The sponsor, MolendiiP Pharma Ltd, the investigational product Dermalexiin, and the study details are fictional and do not represent real clinical trials.

Registry entries must meet official regulatory standards and timelines in a real-world setting. Some technical and operational details have been simplified for educational clarity