Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative.

One expected consequence of increased transparency surrounding clinical trials is that journals will experience a significant growth in the number of manuscript submissions from industry-sponsored research, particularly manuscripts reporting the results of early-phase research. This increase could be substantial since, until recently, about 90% of Phase I studies and 60% of Phase II studies were never published (according to observations from one major company) as these studies tended to be considered of low interest or confirmatory in nature. The increase in the number of trials seeking publication comes on top of underlying, but more gradual, growth in the amount of research being carried out. Since 2005, the bibliographic database Medline has been growing at a rate of 2000–4000 references per day (2), and manuscript submissions to journals continue to increase according to many editors and publishers. In the next few years, the number of reports of clinical trials requiring publication is likely to increase still further. The US Food and Drug Administration Amendments Act (FDAAA) passed in 2007 requires summaries of the results to be posted on the ClinicalTrials.gov website within 12 months of the study end for most trials (3). As the ClinicalTrials.gov results posting format does not permit any textual introduction, interpretation or discussion of the findings, many funders are seeking to publish a traditional journal article at the same time as posting to provide more context. Increased trial registration and results posting may also increase the number of publications on compounds that do not get licensed. Another manifestation of growing transparency, arising from concerns about publication misconduct and poor reporting, is that editors require increasing amounts of information from authors at submission. For example, editors may request copies of related studies to check for overlap and of the study protocol to check that the study is reported responsibly. Journal submission systems also increasingly include questions about research ethics (such as IRB approval and patient consent) and competing interests. To ensure high standards of reporting, journals may also require evidence of compliance with guidelines, for example by submission of a completed CONSORT checklist with the manuscript. Thus, while increasing transparency of reporting may raise standards and bring benefits to readers, it comes at a cost of additional burdens on those reporting research. The evolution of reporting standards and guidelines is shown in Figure 1. There have been suggestions that the publishing ‘ecosystem’ may not be ready to accommodate the expected flood of publications disclosing the results of all industry-sponsored trials which, when combined with increasingly stringent reporting requirements, is putting the system under stress. However, through close collaboration among all interested parties, it is possible to improve the efficiency of the publication process, thus reducing stress on journals, peer reviewers and authors, increasing publishing capacity and transparency, and accelerating public access to clinical trial results. Editors, publishers and pharmaceutical industry employees met recently to share their perspectives on the new disclosure paradigm for industry-sponsored clinical trials and to discuss opportunities to enhance the publication process.