liz wager - medicres world congress 2011
DESCRIPTION
Good Publication Practice GPP (and GPP2)TRANSCRIPT
©Sideview
Good Publication Practice GPP (and GPP2)
Elizabeth Wager PhD
Publications [email protected]
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Disclaimer / Bio
I was lead author on GPP but NOT part of the GPP2 team
I've worked for Janssen-Cilag and GSK I now run my own company, Sideview I'm Chair of COPE (Committee on Publication Ethics)
also on the BMJ Ethics Committee and WAME Ethics Committee
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Why do we need publication guidelines? (What can go wrong?)
Publication bias / selective publication(suppression of negative findings)
Redundant publication (covert)
Bad relations between investigators and trial sponsors (eg access to data)
Authorship problems (eg guest authors)
Ghost writing (unacknowledged use of professional medical writers)
What types of guideline are available?
Contenteg CONSORT, STROBEaim to improve reporting qualitywhat to include in your paper
Processeg ICMJE, GPP, EMWAhow to develop your publication
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1999 2000 2001 200420032002 2005 2006 2007 2008 2009 2010
CBE retreat (GPP proposed)
GPP drafted
GPP2 published
AMWA taskforce
set up
ICMJE trial registration
requirements
ISMPP founded
PhRMA g’lines published EMWA
g’lines published
FDAAA passed
PhRMA g’lines
updated
CSE integrity
white paper
GPP published
ISMPP Code of Ethics
published
GPP for med
comms agencies
published
ISMPP position
statement on med writers
AMWA position
statement WAME policy statement on ghost writing
IFPMA joint statement on publishing clin
trial results
ICMJE Uniform Requirements: 1st
version, 1979
CONSORT: 1st version, 1996
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Background to GPP
Council of Biology Editors retreat ‘Common Aims/Different Languages’ (Nov 1998)
Three-way meeting: Journal editors / Academics / Pharma industry
Revealed editors’ and academics’concerns about industry practices
GPP
First set of guidelines to focus on drug industry research
First guidelines to provide guidance on role of professional medical writers
Referred to ICMJE, CONSORT, etc. Aim = ‘encourage responsible publication
practices’
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What's new in GPP2?
Old
New
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Title
Good Publication Practice for pharmaceutical companies
Good publication practice for communicating company sponsored medical research: the GPP2 guidelines
emphasis on collaboration
and joint responsibilitie
s
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Authors
Wager, Field & Grossman
Graf, Battisti, Bridges, Bruce-Winkler, Conaty, Ellison, Field, Gurr, Marx, Patel, Sanes-Miller, Yarker for ISMPP
much wider consultation
including agency writers
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Reference
CMRO 2003;19:149-54
BMJ 2009;339:b4330doi 10.1136/bmj.b4330
bigger journal!
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Relationship between co. and investigators
The contractual relationship between companies and external investigators should be set out in a written agreement. This should cover publication policies and ownership of data.
Companies should describe obligations for GPP in written publication agreements
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Content of agreements
All authors should have access to the stats reports and tables supporting each publication
Co. should not suppress or veto pub's
Agreement should confirm the sponsor's responsibility:
to grant authors full access to the study data
uphold the authors' freedom to publish the results
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Access to data contd.
"Sponsors have a responsibility to share the data and the analysis with investigators who participated in the study. Sponsors must provide authors and other contributors … with full access to study data, and should do so before the MS writing process begins or before the 1st external presentation of the data"
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Access to data contd.
Authors should be provided with:• study protocol• statistical analysis plan• statistical reports• data tables• clinical study reports• results for posting on trial results websites
Sufficient time should be allowed for authors to … seek further information if they wish (eg access to raw data tables or the study database)
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Agreement (GPP2)
accuracy and completeness of articles
avoid premature pub avoid duplicate pub disclose CoI identify funding
source
ensure appropriate authorship
defines authorship criteria
acknowledge other significant contributions
covered in GPP but
not in agreemen
t
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GPP2 -- agreement Distinguishes AUTHORS' from SPONSOR'S
responsibilities
Authors are responsible for: making "decisions about practical issues
concerning presentation and publication (eg choice of congress or journal)"
"ensuring authorship is attributed appropriately"
this is totally new!
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Reimbursement
Co. can reimburse "reasonable out-of-pocket expenses (eg travel expenses) incurred by contributors"
Co. can pay for "specialised services (eg statistical analysis)"
No honoraria should be paid for authorship of peer-reviewed articles or presentation
nothing on this in GPP
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Writing gp / steering cttee
The formation of a writing committee involving a med writer may be helpful for large, multicentre studies
It may be useful to form a publication steering committee to oversee and produce articles from a research study
Membership does not automatically confer authorship
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Authorship
ICMJE "are a good starting point"
Individual journal requirements should be respected
We recommend using ICMJE criteria
Follow indiv. jnl requirements when these differ from ICMJE
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Authorship contd. Whatever criterion for
listing is used, it should be applied in the same way to both external investigators and company employees
Authorship criteria shld be applied consistently to all contributors including: investigators, sponsor employees and individuals contracted by the sponsor
mentions contractors / freelancers
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Authorship Medical writers may qualify for authorship
eg if they did "extensive literature searches" and summarised the literature for a review article
AND are "willing to take public responsibility for relevant portions of the content"
similar to EMWA g'lines
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Acknowledgements
Should list those people who made a significant contribution to the study but do not qualify as authors … should also acknowledge funding and co. involvement in analysis / writing
Recommends specific wording
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Role of medical writers
may provide publication expertise and assistance with writing, editing or preparing manuscripts
are required to have a good understanding of publication ethics and conventions and ensure, through collaboration with authors, that their work is scientifically appropriate
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New stuff
Abstracts for local meetings may include authors who are not on the primary article
For review articles: care should be taken to ensure appropriate description of contributions from med writers
Study limitations should be described
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Institutional policies
Authors should provide sponsors with a copy of their institution's publication policy
Written agreement "must respect the institutional policies of authors"
"Individuals must not be asked to violate the policies of their institutions"
not mentioned
in GPP
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DocumentationCompanies should document how publications are
initiated and developed and should retain: publication agreements details of intellectual input, directions &
contributions main version of draft / comments workflow and timelines approval from authors for submission list of participants other than authors who were
allowed to review or comment on the document
new section!
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Characteristic Demonstrated by
Integrity accurate, objective, balanced writingfull access to data for authorsabsence of duplicate publicationhonest attribution of authorship
Completeness clear description of research hypothesisreporting detail to ensure unbiased presentationcomplete and honest refs to related workuse of unique trial identifiersdiscussion of limitationspublishing results regardless of outcome
Transparency making clear sources of fundingdisclosing potential CoIsacknowledgements, including role of sponsor
Accountability being accountable for the workassigning a guarantor
Responsibility publishing in timely mannerrespecting intellectual propertyrespecting responsibilities for GPP
new checklis
t
Conclusions
GPP2 builds on GPP Aims to encourage responsible publication
practices Outlaws non-publication, selective
publication, redundant publication Describes sponsors’ role in publication
development and planning
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Publication is the final stage of research, you also need:
Ethical design / review / approval Ethical conduct of research Appropriate analysis Good process and content for reporting Ethical publishing (reviewers, editors)
see www.publicationethics.org (COPE)
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'Always do right – this will gratify some and
astonish the rest'
Mark Twain