ABSTRACT
Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly. Please see related article: http://www.biomedcentral.com/1741-7015/12/214.
Subject(s)
Authorship/standards , Clinical Trials as Topic , Disclosure/standards , Drug Industry/economics , Financial Support , Practice Guidelines as Topic , Biomedical Research/ethics , Biomedical Research/standards , Clinical Trials as Topic/economics , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Conflict of Interest , Decision Making , Ethics, Professional , Financial Support/ethics , Humans , Publications/ethics , Publications/standardsSubject(s)
Clinical Trials as Topic/methods , Drug Industry/organization & administration , Periodicals as Topic/standards , Publications/standards , Research Support as Topic/organization & administration , Statistics as Topic/education , Statistics as Topic/organization & administration , Access to Information , Clinical Trials as Topic/ethics , Drug Industry/ethics , Guidelines as Topic , Humans , Periodicals as Topic/ethics , Publications/ethics , Publishing/standards , Research Support as Topic/ethics , United StatesABSTRACT
Biomedical journals and the pharmaceutical industry share the goals of enhancing transparency and expanding access to peer-reviewed research; both industries have recently instituted new policies and guidelines to effect this change. However, while increasing transparency may elevate standards and bring benefits to readers, it will drive a significant increase in manuscript volume, posing challenges to both the journals and industry sponsors. As a result, there is a need to: (1) increase efficiency in the submission process to accommodate the rising manuscript volume and reduce the resource demands on journals, peer reviewers, and authors; and (2) identify suitable venues to publish this research. These shared goals can only be accomplished through close collaboration among stakeholders in the process.In an effort to foster mutual collaboration, members of the pharmaceutical industry and the International Society for Medical Publication Professionals founded a unique collaborative venture in 2008 - the Medical Publishing Insights and Practices initiative (MPIP). At an MPIP roundtable meeting in September 2009,journal editors, publishers and industry representatives identified and prioritized opportunities to streamline the submission process and requirements, and to support prompt publication and dissemination of clinical trial results in the face of increasing manuscript volume. Journal and sponsor participants agreed that more author education on manuscript preparation and submission was needed to increase efficiency and enhance quality and transparency in the publication of industry-sponsored research. They suggested an authors'guide to help bridge the gap between author practices and editor expectations.To address this unmet educational need, MPIP supported development of an Authors' Submission Toolkit to compile best practices in the preparation and submission of manuscripts describing sponsored research.The Toolkit represents a unique collaboration between the pharmaceutical industry and biomedical journals,and reflects both groups' perspectives on how authors can help raise standards and increase efficiency in publishing industry-sponsored studies. The information provided in the toolkit can be useful to help authors navigate the manuscript
