The sunshine act and medical publications: Guidance from professional medical associations.

OBJECTIVE: To review guidance from professional medical associations to physicians on the Sunshine Act, with a focus on industry support for medical publications. METHODS: Using 'Sunshine Act' as a search term, we searched PubMed (dates February 2013 to November 2014) and the 'grey literature' using Google and Google Scholar. Online information was extracted from websites of pre-identified professional medical associations. RESULTS: Some professional medical associations have published peer-reviewed recommendations, position statements or general advice on their websites and in journals around the Sunshine Act. Associations also provided broad online educational resources for physicians. There was universal agreement between peer-reviewed publications, including guidelines, for the need for full transparency and disclosure of industry support. Surveys by some professional associations showed variance in opinion on the forecasted impact of the Sunshine Act on physician-industry relationships. There was scarce information specifically related to reporting requirements for industry-supported medical publications. CONCLUSIONS: There is a shortage of information for physicians from professional associations regarding the Sunshine Act and support for medical publications. Due to the lack of clear guidance regarding support for publications, there are presently varying interpretations of the Sunshine Act. The literature debates the potential impact of the Sunshine Act and expresses some concerns that physician-enabled innovation in drug development may be hindered.

Authors' Submission Toolkit: a practical guide to getting your research published.

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