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©Sideview
Ethical research publication: who’s responsibility is it?
Liz Wager PhD
Publications Consultant,
Sideview [email protected]
"A discovery does not exist until it is safely reviewed
and in print"
EO Wilson (1929 - )
"Words are, of course, the most powerful drug
used by mankind"
Rudyard Kipling (1865-1936)
Publication matters
Trial participants expect findings to contribute to medical knowledge
Misrepresenting findings (or not publishing them at all) is unethical
But who’s responsible for ensuring good practice?
©Sideview
Research and publication ethics are a spectrum
Unethical research design
Data fabrication
Inappropriate analysis
Lack of patient consent
Data falsification
Image manipulation
Plagiarism
Redundant publication
Design Analysis Reporting
Authorship abuse
Conduct
Selective / non-
publication
Many players are (or could be) involved:
Researchers (mentors / supervisors) Journals (editors / publishers) Funders Institutions Professional / academic organizations RECs Regulators
©Sideview
Does the system need to change?
Half of all clinical trials are never published
©SideviewRoss et al PLOS Med 2009;e1000144
Does the system need to change?
About 50% of studies presented at conferences never get published in full (Scherer et al JAMA 1994;272:158-62)
Cohort of RCTs submitted to Swiss REC (to 1998) 52% published by 2006 (von Elm et al Swiss Med Wkly 2008;138:197-203)
22% of trials on CT.gov reported results within 1 year of study end (Prayle et al BMJ 2012)
©Sideview
Does the system need to change?
German drug assessment body found 74% of data on the antidepressant reboxitine was unpublished
Including the unpublished data changed their recommendation (to “ineffective and potentially harmful”)
©Sideview
Wieseler et al BMJ 2010;341:c4942Eyding et al BMJ 2010;341:c4737
Does the system need to change?
585 registered trials with >500 participants Completed before Jan 2009 29% (171) unpublished in November 2012 Of the unpublished trials 78% did not have results posted
on CT.gov “The lack of availability of results from these trials … constitutes a failure to
honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation. Additional safeguards are needed to ensure timely public dissemination of trial data.”
©Sideview
Jones et al BMJ 2013;347:f6104published
29 Oct 2013!
©Sideview
Does the system need to change?
Comparison of protocols cf publications (N=102) Found incomplete reporting of:
• 50% of efficacy• 65% of safety/AE outcomes
Statistically significant outcomes more likely to be reported
62% of trials had at least one primary outcome changed, introduced or omitted
Chan et al JAMA 2004;291:2457-65
Change probably requires a ‘systems’ approach
Incentives Guidelines Training ‘Infrastructure’ / technology
©Sideview
Many players should be involved:
Researchers (mentors / supervisors) Journals (editors / publishers) Funders Institutions Professional / academic organizations RECs Regulators
©Sideview
Influence on clinical trials
Funding decision
Publication
Design Analysis Reporting
Conduct
Registration
Ethical approval
Funders RECs
Institutions
Agreement / contract
Regulators
Publishers
Opportunities
Funders could make final payment conditional on report / publication (eg HTA)
Funders could make publication of previous projects a criterion for future funding
Institutions could reward responsible publication (quality and quantity)
Institutions should promote and enforce good authorship practices
Alternative venues for disseminating results (registers, institutional repositories, databanks, websites)*
©Sideview
alternatives to traditional journals
©Sideview
More opportunities
Institutions and professional bodies could offer training in RCR / publication ethics
Journals could require use of reporting guidelines (or develop more structured reports)
Funders, RECs, journals could require trial registration
©Sideview
New trials registered at clinicaltrials.gov May – Oct 2005
Journal policies can be effectiveICJME
deadline
Good news! (Sept 2013)
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Research ethics committees could help prevent other serious problems
Unethical research design
Data fabrication
Inappropriate analysis
Lack of patient consent
Data falsification
Image manipulation
Plagiarism
Redundant publication
Design Analysis Reporting
Authorship abuse
Conduct
Selective / non-
publication
Could RECs extend their remit?
Require researchers to publish all studies (on trial register / repository / journal)
Encourage / check posting on institutional repositories / company websites
Make publication of previous projects a requirement for future approvals
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Are RECs behaving unethically?
“The fate of scientific data is no idle issue. Reliable research syntheses depend on ensuring that as much as possible of the potentially relevant evidence is taken into account in systematic reviews. .. Contrary to a widely held assumption, it is investigators and some research funders—and not necessarily journal editors—who are primarily responsible for under-reporting of research … Prevention of this form of scientific misconduct must therefore involve the bodies to which investigators are answerable, in particular research ethics committees.
The consequences of under-reporting of research are that patients are being expected to accept the harmful side effects of ineffective forms of care; accept advice about the effects of health care which is based on evidence that is less complete than it should be;… and contribute to research … which may not be published if the results come as a disappointment or an embarrassment to the investigators or sponsors.
©Sideview
Savulescu et al BMJ 1996;313:1390-3
Conclusions
Unethical reporting is a ‘systems problem’ Unethical reporting may harm patients,
harm trial participants, waste resources Responsible research reporting is
EVERYBODY’s responsibilityincluding RECs
©Sideview