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  4. Ethics and accountability for clinical trials

Ethics and accountability for clinical trials

Spinal Cord, 2024 · DOI: https://doi.org/10.1038/s41393-024-00980-z · Published: March 18, 2024

Spinal Cord InjuryResearch Methodology & Design

Simple Explanation

ClinicalTrials.gov, a database for clinical trial information, posted a disclaimer disowning accountability for the accuracy of data uploaded to the site. This disclaimer undermines the database's purpose, which is to provide information about clinical research studies to the public and support policies that require sharing of trial results. The lack of oversight leads to inconsistencies in the information posted, affecting vulnerable participants and creating distrust in science.

Study Duration
Not specified
Participants
People living with spinal cord injury
Evidence Level
Not specified

Key Findings

  • 1
    There is ambiguous classification of intervention type across trials, hindering understanding of available trials.
  • 2
    Many spinal cord injury studies are registered in the 'Not Applicable Phase,' undermining the reliability of their scientific status.
  • 3
    Lack of transparency around adverse events, coupled with the disclaimer, makes informed decision-making for trial participation impossible.

Research Summary

ClinicalTrials.gov posted a disclaimer in May 2023 disowning accountability for errors in data, which undermines its stated purpose. Inconsistencies in intervention classification and phase designation, particularly in spinal cord injury trials, threaten the database's integrity. The authors recommend clear definitions, consistency in intervention types, transparency about adverse events, and investment in oversight to improve the database's utility.

Practical Implications

Improved Data Quality

Implementing clear and consistent definitions for intervention types and trial phases will improve the accuracy and reliability of information on ClinicalTrials.gov.

Enhanced Transparency

Greater transparency regarding adverse events and study protocols will enable better-informed decision-making for trial participants.

Restored Trust

Addressing inconsistencies and providing oversight will help restore trust in ClinicalTrials.gov as a reliable resource for clinical trial information.

Study Limitations

  • 1
    Lack of resources for thorough review of all studies.
  • 2
    Reliance on self-reporting by study sponsors and investigators.
  • 3
    Challenges in enforcing compliance with reporting requirements.

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