Back to resultsCoordinated Assessment of Notifications of Trials Containing Overt Published Errors
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reporting of discrepancy to journal
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring Discrepancy, Committee on Publication Ethics, Correction, Erratum, Retraction
Eligibility Criteria
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
Sites / Locations
- International Centre for Circulatory Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Provision of information
Arm Description
Reporting of discrepancy to journal
Outcomes
Primary Outcome Measures
Time to correction, retraction, or other notification to the readership of discrepancy
Secondary Outcome Measures
Time to initial response from journal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01901523
Brief Title
Coordinated Assessment of Notifications of Trials Containing Overt Published Errors
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Discrepancy, Committee on Publication Ethics, Correction, Erratum, Retraction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Provision of information
Arm Type
Experimental
Arm Description
Reporting of discrepancy to journal
Intervention Type
Behavioral
Intervention Name(s)
Reporting of discrepancy to journal
Other Intervention Name(s)
Mathematical impossibility, Factual impossibility, Contradiction, Arithmetical impossibility, Error, Discrepancies, Fractional patients, Impossible percentage, Contradictory data, Negative standard deviation, Negative NYHA
Primary Outcome Measure Information:
Title
Time to correction, retraction, or other notification to the readership of discrepancy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to initial response from journal
Time Frame
0-4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darrel P Francis, MA FRCP MD
Phone
+44 207 594 1093
Email
d.francis@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Graham D Cole, MA MB MRCP
Phone
+44 207 594 1093
Email
g.cole@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MA MD FRCP
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
International Centre for Circulatory Health
City
London
ZIP/Postal Code
W2 1LA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23830344
Citation
Francis DP, Mielewczik M, Zargaran D, Cole GD. Autologous bone marrow-derived stem cell therapy in heart disease: discrepancies and contradictions. Int J Cardiol. 2013 Oct 9;168(4):3381-403. doi: 10.1016/j.ijcard.2013.04.152. Epub 2013 Jul 2.
Results Reference
background
PubMed Identifier
24778175
Citation
Nowbar AN, Mielewczik M, Karavassilis M, Dehbi HM, Shun-Shin MJ, Jones S, Howard JP, Cole GD, Francis DP; DAMASCENE writing group. Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis. BMJ. 2014 Apr 28;348:g2688. doi: 10.1136/bmj.g2688.
Results Reference
background
Links:
URL
http://www1.imperial.ac.uk/medicine/people/d.francis/
Description
Reliable cardiovascular research
Learn more about this trial
Coordinated Assessment of Notifications of Trials Containing Overt Published Errors
We'll reach out to this number within 24 hrs