Funding sources of the trials included in Cochrane reviews: pros and cons of disclosure in the abstract and plain language summary

Article type
Authors
Napoli M, Wale J
Abstract
Background: Funding of drug studies by the pharmaceutical industry is associated with outcomes favorable to the funders. Many clinicians, journalists and consumers are unaware of this bias. Cochrane abstracts and plain language summaries (PLS) are freely available, and many people unfamiliar with The Cochrane Collaboration access them on the Internet. Given this wide dissemination, it is likely that these are the only sections of a Cochrane review that will be read by a majority. Last year, after soliciting opinions from CCNet’s membership, we proposed the reporting of funding sources in the abstract/PLS of all drug reviews at the XV Colloquium and as an agenda item for the Steering Group meeting. The Cochrane Handbook for Systematic Reviews of Interventions (CH) was under revision in 2007. Objectives: To determine whether Cochrane policy should be changed to recommend the reporting of funding sources of trials in the abstract/PLS. Methods: We solicited advice from people within Cochrane who have published about bias in industry-funded research or were revising the CH. We initiated a discussion after our presentation at the XV Colloquium. The revised CH was searched. Results: Arguments against disclosure: (1) trials can have many biases, other than industry funding; (2) should be left to authors’ discretion; (3) no space for yet-another recommendation. Compromise suggestion: confine recommendation to reviews of drugs known to be overprescribed worldwide (e.g., statins, proton pump inhibitors). Strongest argument for disclosure is the new CONSORT statement for reporting on trials in abstracts, which recommends listing the source of funding. The revised CH acknowledges the distorting influences of pharmaceutical industry funding, and it also recommends reporting of funding sources in ‘‘Characteristics of included studies’’. No recommendation, however, is made about disclosure in the abstract/PLS. Conclusions: There are mixed reactions to disclosure, despite the fact that the CH says the abstract/PLS should be read as stand-alone documents. Cochrane abstracts are disseminated freely on MEDLINE, Science Citation Index and the Internet. Thus, a significant portion of the audience for Cochrane reviews is denied information crucial to informed decision making when the abstract/PLS omits funding sources of included trials.