Coordinated Assessment of Notifications of Trials Containing Overt Published Errors

Sponsor

Imperial College London (Other)

Overall Status

Unknown status

CT.gov ID

NCT01901523

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Reporting of discrepancy to journal	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to correction, retraction, or other notification to the readership of discrepancy [12 months]

Secondary Outcome Measures

Time to initial response from journal [0-4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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