ABSTRACT
These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.
Subject(s)
Authorship , Biomedical Research , HumansABSTRACT
BACKGROUND: Evolving standards of good publication practice (GPP) and a survey conducted in 2009 of authors, who were investigators and researchers not employed by the company prompted changes to GSK Vaccines' publication practices. We conducted a follow-up survey in 2012 to assess the company's revised practices and to evaluate understanding of GPP among investigators and researchers who had previously authored at least one publication in collaboration with GSK Vaccines. METHODS: The 50-question web-based survey addressed authoring practices and transparency of decision-making. Investigators and researchers (n = 1,273) who had authored at least one publication reporting on GSK Vaccines-sponsored human research since 2007, were invited to participate. Responses to 37 closed questions are presented. The remaining 13 questions were open-ended or did not concern publication practices. RESULTS: A total of 415 external authors (32.6%) responded. International Committee of Medical Journal Editors (ICMJE) authorship criteria were clear to most respondents (78.1%); 7.7% found they were unclear. The majority of participants (86.8%) found GSK Vaccines' authorship questionnaire a suitable tool to assess eligibility for authorship as per the ICMJE criteria. However, only 68.5% felt that the outcome of the questionnaire is communicated appropriately and 58.3% felt well informed on changes in authorship. Nearly two-thirds (62.9%) of respondents felt that having a pharmaceutical company employee as lead author makes manuscript acceptance less likely. Access to relevant data was regarded as sufficient by 78.5% of respondents. Briefing meetings before publication start, publication steering committees and core writing teams were recognized as valuable publication practices. Professional medical writing support was seen as adding value to publication development by 87.7% of participants. Most respondents agreed that manuscript discussions should start early, with 81.7% stating that they were in favor of introducing a formalized 'author agreement' at the publication start. CONCLUSIONS: GSK Vaccines made changes to its publication practices to ensure improved transparency and better involvement of external authors. The results of this survey suggest that these changes have been effective to a large extent. They confirm the need for effective and timely communication, as well as transparent processes for authorship and decision-making during publication development. The identified gaps in GPP will help to guide further improvements to the company's policies on publication practices.
