Authors' reports about research integrity problems in clinical trials

Background: There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research. Methods: We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about. Results: We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct. Conclusions: Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct. (c) 2005 Elsevier Inc. All rights reserved.