Heart FailureNCT01901523
Coordinated Assessment of Notifications of Trials Containing Overt Published Errors
A study testing Reporting of discrepancy to journal in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Reporting of discrepancy to journal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Discrepancy has already been corrected by an erratum
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
International Centre for Circulatory Health
London, London, W2 1LA
About this study
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 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Reporting of discrepancy to journal
- Keywords
- Discrepancy, Committee on Publication Ethics, Correction, Erratum, Retraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reporting of discrepancy to journalBehavioural
Also called Mathematical impossibility, Factual impossibility, Contradiction, Arithmetical impossibility
| Study group | Role | What they receive |
|---|---|---|
| Provision of information | Experimental | Reporting of discrepancy to journal Receives: Behavioral: Reporting of discrepancy to journal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to correction, retraction, or other notification to the readership of discrepancy
Measured: 12 months
Secondary outcomes (1)
Time to initial response from journal
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrel Francis, Imperial College London
- Investigators
- Darrel P Francis, MA MD FRCP, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901523
- Sponsor's protocol ID
- ICCH/13/SFI/Str
- Status last verified
- May 2014
- First submitted
- 12 Jul 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23830344Nowbar 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.
PubMed 24778175
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.
- ClinicalTrials.gov ID
- NCT01901523
- Acronym / sponsor ID
- ICCH/13/SFI/Str
- Conditions
- Heart Failure
- Keywords
- Discrepancy, Committee on Publication Ethics, Correction, Erratum, Retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Provision of information | Experimental | Behavioral: Reporting of discrepancy to journalReporting of discrepancy to journal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Discrepancy has already been corrected by an erratum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reporting of discrepancy to journalAlso: Mathematical impossibility, Factual impossibility, Contradiction, Arithmetical impossibility | Behavioural | Provision of information |
Primary outcome
Time to correction, retraction, or other notification to the readership of discrepancy
Time frame: 12 months
1 secondary outcome
Time to initial response from journal
Time frame: 0-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Background: PubMed 23830344Francis 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.
- Background: PubMed 24778175Nowbar 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.
- Reliable cardiovascular researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrel P Francis, MA MD FRCP study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reporting of discrepancy to journal in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darrel P Francis, MA FRCP MD (+44 207 594 1093, d.francis@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to correction, retraction, or other notification to the readership of discrepancy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901523, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.