Abstract
BackgroundEvolving 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.MethodsThe 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.ResultsA 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.ConclusionsGSK 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.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-446) contains supplementary material, which is available to authorized users.
Highlights
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
The good publication practice (GPP) guidelines, which were published in 2003 [17] and revised by the International Society for Medical Publication Professionals (GPP2; GPP3 guidelines are in development), focus on industrysponsored research [1]
There are guidelines for reporting specific study types, such as the Consolidated Standards of Reporting Trials (CONSORT) for reporting randomized trials, the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines for economic evaluations of health interventions [18]
Summary
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. Practices in the publication of research study results have been questioned in relation to issues such as reporting bias, inappropriate authorship and inaccurate disclosure of conflicts of interest [2,3,4,5,6,7,8,9], for industry-sponsored studies, and for publicly-funded or academic trials [10,11,12]. This can lead to a loss of confidence in the evidence base used to inform public health decisions [13,14,15]. There are guidelines for reporting specific study types, such as the Consolidated Standards of Reporting Trials (CONSORT) for reporting randomized trials, the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines for economic evaluations of health interventions [18]
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