Coordinated Assessment of Notifications of Trials Containing Overt Published Errors

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01901523
• Other study ID #: ICCH/13/SFI/Str
• Status: Not yet recruiting
• Phase: N/A
• First received: July 12, 2013
• Last updated: May 16, 2014
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Imperial College London
• Contact: Darrel P Francis, MA FRCP MD
• Phone: +44 207 594 1093
• Email: d.francis[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Reporting of discrepancy to journal

Locations

Country	Name	City	State
United Kingdom	International Centre for Circulatory Health	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to correction, retraction, or other notification to the readership of discrepancy		12 months	No
Secondary	Time to initial response from journal		0-4 weeks	No

External Links

•   Reliable cardiovascular research