Failure to Update ClinicalTrials.gov Record for a Clinical Trial - Scorecard - MDSpire
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Neglecting to Revise ClinicalTrials.gov Entry for a Research Study

  • By

  • Dost Ongur

  • September 1, 2026

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Clinical Scorecard: Neglecting to Revise ClinicalTrials.gov Entry for a Research Study

At a Glance

CategoryDetail
ConditionClinical Trials Reporting
Key MechanismsProtocol modifications and registration discrepancies
Target PopulationResearchers and clinicians involved in clinical trials
Care SettingClinical 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        • Misinterpretation of trial findings due to outdated registration information.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.

        Related Resources & Content

        Original Source(s)

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