Investigator experiences with financial conflicts of interest in clinical trials

Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.An estimated 20,000 trials are initiated internationally each year [1] with over 500 published each month [2]. Participants volunteer for these trials under the assumption that their efforts will contribute to the advancement of science. Accordingly, study results need to be objective, publicly available, and responsibly applied to advance knowledge and healthcare practice.Concern about the potential impact of financial conflicts of interest (fCOI) on research conduct has led to recommendations for clinical trial practices designed to maintain an investigator's independence and to avoid the introduction of bias and suppression of results. Practices that promote the objectivity of researc