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Table 2 Section by section: strengths and weaknesses of the ICMJE Recommendations as a barrier to marketing bias (December 2015 Recommendations)

From: The ICMJE Recommendations and pharmaceutical marketing – strengths, weaknesses and the unsolved problem of attribution in publication ethics

Section

Strengths

Weaknesses

IIA1

Contributor listings

• Bookkeeping of author accountability.

• Helps enforce integrity of publication.

• Do not separate academic and company coauthors.

• Small print, vague language assist attribution bias.

II A2

Authorship formula

• Encourages high scientific standards.

• Encourages rigorous checking by authors.

• Bans guest authorship.

• Facilitates byline avoidance.

• No advice on author order.

• No company-level authorship or accountability.

II A3

Acknowledgements

• Bookkeeping of non-author contributions, accountability.

• Omit key commercial information.

• Small print, vague language assist attribution bias.

II A3

Writers barred from coauthorship

• None.

• Supports commercial production of ghostwritten manuscripts.

• Facilitates and downplays commercial content influence.

II B

Conflict of interest

• Comprehensive net for author financial interests.

• Salient interests not highlighted.

• No contributor interests.

• No corporate interests.

II B

Role of funding source

• Company role in conducting research, decision to publish reported.

• No requirement to report company instigation, database ownership or identity of marketed product.

II B

Access to data

• Discourages restrictions on author access to data.

• No requirement for independent statistical analysis.

• No demand for contractual rights to data access and unrestricted usage.

IIB

Right to publish

• Authors discouraged from agreeing limitations to their right to publish.

• Should insist on contractual rights guaranteeing publishing rights for academic coauthors.

IIID

Overlapping publications

• Reduces discourse bias by identifying / reducing duplicate articles.

• Limited ability to prevent repetition of commercial content.

IIIG

Supplements and series

• Editorial control defended.

• Notification of product being marketed.

• None – but should apply to all commercially financed articles.

III L

Trial registration

• Helps locate published commercial trials.

• Helps expose non- or inadequate publication.

• None.

IV A2

Reporting guidelines

• CONSORT compliance required.

• Minimal methodological standards supported.

• Readers referred to EQUATOR and National Library of Medicine (NLM) listings of guidelines - these include trade guidelines compatible with marketing.

IV A3b

Funding source, trial identifier listed in Abstract

• Visibly identifies presence of company in PubMed-searchable format.

• The terms “funding,” “support” and “sponsorship” misrepresent actual instigating/proprietary role of commerce.

IV A3d

Role of “contracted organization” described in Methods

• Reveals involvement of company to readers.

• Also identifies contract research organizations.

• Stipulation is vaguely worded and omits key details e.g. company instigation, database ownership, identity of marketed product.