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Good Publication Practice GPP (and GPP2)

Elizabeth Wager PhD

Publications Consultantliz@sideview.demon.co.uk

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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