Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

Abstract

ObjectiveTo gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry.Design/settingWeb-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013.Participants469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies (‘industry’, n=144), communication agencies (‘agency’, n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD.ResultsOver 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors’ Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents’ companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents’ departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results.ConclusionsWithin this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.

Author attitudes to professional medical writing support

“…In this case, we believe it would be helpful for authors and journal editors to understand the background, scientific and publications expertise of PMWs, and perhaps the medical communications industry professional associations could educate about the credentials and skills of medical writers. For example, in a recent survey of medical publication professionals, 38% of medical writing agency respondents were aware of their company being asked (within the last 12 months) by an author or sponsor to do something that they believed would contravene ethical guidelines, and after intervention by the agency, the request was withdrawn or amended in 92% of cases 28 . Specifically regarding authorship practices, 33% of industry respondents and 46% of agency respondents had, within the last 12 months, recommended to a lead author that a co-author should be removed from an abstract or manuscript in development for failure to meet authorship criteria 28 .…”

Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications

“…Professional medical writers often have a background in scientific research with an extensive peer-reviewed publication record and many have an advanced degree 18,19 . Medical writers also improve the quality of publications through their language, communication and formatting skills, project management abilities, and knowledge of publication ethics and guidelines 3,4,10,[20][21][22] .…”

Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review

“…148 English), ethics (reporting of non-pre-specified outcomes) and timeliness (time to publication). The 155 improvement in CONSORT adherence associated with PMWS is perhaps unsurprising, given that 156 professional medical writers are routinely trained in Good Publication Practice (GPP3) for the 157 development of peer-reviewed manuscripts [23]; GPP3 guidelines state that authors should follow 158 established reporting standards, including CONSORT [8,9]. Although PMWS was associated with 159 improved adherence to CONSORT, it was not associated with improved adherence to CONSORT-A, 160…”