Coordinated Assessment of Notifications of Trials Containing Overt Published Errors
Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 19, 2014
May 1, 2014
1.2 years
July 12, 2013
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to correction, retraction, or other notification to the readership of discrepancy
12 months
Secondary Outcomes (1)
Time to initial response from journal
0-4 weeks
Study Arms (1)
Provision of information
EXPERIMENTALReporting of discrepancy to journal
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Discrepancy has already been corrected by an erratum
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Circulatory Health
London, London, W2 1LA, United Kingdom
Related Publications (2)
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.
PMID: 23830344BACKGROUNDNowbar 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.
PMID: 24778175BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Darrel P Francis, MA MD FRCP
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiology
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 17, 2013
Study Start
June 1, 2014
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
May 19, 2014
Record last verified: 2014-05