Dataset Information

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

ABSTRACT: OBJECTIVE:To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. DESIGN/SETTING:Web-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. PARTICIPANTS:469 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. RESULTS:Over 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reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines.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. CONCLUSIONS:Within 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.

SUBMITTER: Wager E

PROVIDER: S-EPMC3996822 | biostudies-other | 2014 Apr

REPOSITORIES: biostudies-other

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

Wager Elizabeth E Woolley Karen K Adshead Viv V Cairns Angela A Fullam Josh J Gonzalez John J Grant Tom T Tortell Stephanie S

BMJ open 20140419 4

<h4>Objective</h4>To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry.<h4>Design/setting</h4>Web-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.<h4>Participants</h4>469 individuals involved in publishing industry-sponsored research i ...[more]

PMID: 24747794

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Project description:BackgroundMapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time.MethodsWe analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials.Results119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%).ConclusionsBased on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries.

Project description:BackgroundThe German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial's impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort.MethodsThe research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov . Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication's target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.ResultsWe included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).ConclusionsThe results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

Project description:ImportanceDuplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication.ObjectiveTo assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication.Design, setting, and participantsIn this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration.ExposuresIndividual randomized clinical trials with positive vs negative results.Main outcomes and measuresJournal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them).ResultsAmong 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings.Conclusions and relevanceIn this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication bias exists when the main articles of randomized clinical trials were published in Chinese, potentially misleading readers and compromising journals and evidence synthesis.

Project description:OBJECTIVE:Worldwide, the respiratory syncytial virus (RSV) represents the predominant viral agent causing bronchiolitis and pneumonia in children. To conduct research and tackle existing healthcare disparities, RSV-related research activities around the globe need to be described. Hence, we assessed the associated scientific output (represented by research articles) by geographical, chronological and socioeconomic criteria and analysed the authors publishing in the field by gender. Also, the 15 most cited articles and the most prolific journals were identified for RSV research. DESIGN:Retrospective, descriptive study. SETTING:The NewQIS (New Quality and Quantity Indices in Science) platform was employed to identify RSV-related articles published in the Web of Science until 2013. We performed a numerical analysis of all articles, and examined citation-based aspects (eg, citation rates); results were visualised by density equalising mapping tools. RESULTS:We identified 4600 RSV-related articles. The USA led the field; US-American authors published 2139 articles (46.5%% of all identified articles), which have been cited 83?000 times. When output was related to socioeconomic benchmarks such as gross domestic product or Research and Development expenditures, Guinea-Bissau, The Gambia and Chile were ranked in leading positions. A total of 614 articles on RSV (13.34% of all articles) were attributed to scientific collaborations. These were primarily established between high-income countries. The gender analysis indicated that male scientists dominated in all countries except Brazil. CONCLUSIONS:The majority of RSV-related research articles originated from high-income countries whereas developing nations showed only minimal publication productivity and were barely part of any collaborative networks. Hence, research capacity in these nations should be increased in order to assist in addressing inequities in resource allocation and the clinical burden of RSV in these countries.

Dataset Information

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

Publications

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

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