Ten Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research: A Joint Journal and Pharmaceutical Industry Perspective

Abstract

The credibility of industry-sponsored clinical research has suffered in recent years, undercut by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest.1,2 In response, many pharmaceutical companies have integrated best practices and recommendations from groups such as the International Committee of Medical Journal Editors (ICMJE), the Good Publication Practice guidelines, the Committee on Publication Ethics, the EQUATOR (Enhancing the QUAlity and Transparency Of health Resources) Network, and the Medical Publishing Insights and Practices (MPIP) initiative into their internal policies and standard operating procedures.3-10 However, a credibility gap remains: some observers, including some journal editors and academic reviewers, maintain a persistent negative view of industry-sponsored studies.11 Given industry's pivotal role in the development of new therapies, further improvements in research conduct and disclosure are needed across the industry-investigator-editor enterprise to restore confidence in industry-sponsored biomedical research. In 2008, the MPIP was founded by members of the pharmaceutical industry and the International Society for Medical Publication Professionals to elevate trust, transparency, and integrity in publishing industry–sponsored studies through education and creation of a discussion forum among industry research sponsors and biomedical journals.12,13 In 2010, the MPIP convened a roundtable of 23 journal editors and industry representatives (see the “Acknowledgments” section for a list of MPIP participants) to characterize the persistent and perceived credibility gap in industry-sponsored research and identify approaches to resolve it. Attendees agreed that there have been important improvements in the conduct and reporting of industry-sponsored studies during the past 5 years, but several opportunities remain for additional improvement. Attendees reached consensus on a top 10 list of recommendations (Table), intended to serve as a call to action for all stakeholders—authors, journal editors, research sponsors, and others—to enhance the quality and transparency of industry-sponsored clinical research reporting. Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source. TABLE Top 10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research