Coordinated Assessment of Notifications of Trials Containing Overt Published Errors

May 16, 2014 updated by: Darrel Francis, Imperial College London

Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.

Clinical research, like all science, is self-correcting, with errors detected by the scientific community and communicated to the publishing journals, which then relay the information (and its resolution) to its readers. If this relaying process fails, science grinds to a halt. In this study we are testing its integrity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This prospective study documents the outcome of notification to journal editorial boards (or equivalent authorities) of factually incorrect or inconsistent claims, in reports they have published.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1LA
        • International Centre for Circulatory Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Report of a clinical trial in humans of treatment of heart disease with bone marrow derived stem cells
  • Report containing discrepancy by reference to same report or another report

Exclusion Criteria:

  • Discrepancy has already been corrected by an erratum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provision of information
Reporting of discrepancy to journal
Behavioral: Reporting of discrepancy to journal
Other Names:
  • Mathematical impossibility
  • Factual impossibility
  • Contradiction
  • Arithmetical impossibility
  • Error
  • Discrepancies
  • Fractional patients
  • Impossible percentage
  • Contradictory data
  • Negative standard deviation
  • Negative NYHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to correction, retraction, or other notification to the readership of discrepancy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to initial response from journal
Time Frame: 0-4 weeks
0-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Study Chair: Darrel P Francis, MA MD FRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICCH/13/SFI/Str

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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