Neglecting to Revise ClinicalTrials.gov Entry for a Research Study
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By
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Dost Ongur
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September 1, 2026
Clinical Scorecard: Neglecting to Revise ClinicalTrials.gov Entry for a Research Study
At a Glance
| Category | Detail |
| Condition | Clinical Trials Reporting |
| Key Mechanisms | Protocol modifications and registration discrepancies |
| Target Population | Researchers and clinicians involved in clinical trials |
| Care Setting | Clinical research and trial management |
Key Highlights
- Concerns arose regarding trial findings due to unupdated ClinicalTrials.gov records.
- Significant protocol modifications occurred before and during participant recruitment.
- The published article included a prospectively amended trial protocol as a Supplement.
- Authors acknowledged the error of not updating the ClinicalTrials.gov record in real time.
- Debate exists over the appropriateness of the CATIE study as a comparator.
Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Risks
- Misinterpretation of trial findings due to outdated registration information.
Patient & Prescribing Data
Not applicable as the focus is on clinical trial reporting.
Not applicable as the focus is on clinical trial reporting.
Clinical Best Practices
- Ensure real-time updates of ClinicalTrials.gov entries for ongoing studies.
- Publish protocol modifications in peer-reviewed journals to maintain transparency.
- Engage with the research community to clarify any concerns regarding trial integrity.
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