title: Investigator experiences with financial conflicts of interest in clinical trials.
abstract: BACKGROUND
  Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
authors.affiliation: Women's College Research Institute at Women's College Hospital, Toronto, Canada. paula.rochon@utoronto.ca
authors.forename: Paula A
authors.initials: PA
authors.lastname: Rochon
authors.forename: Melanie
authors.initials: M
authors.lastname: Sekeres
authors.forename: John
authors.initials: J
authors.lastname: Hoey
authors.forename: Joel
authors.initials: J
authors.lastname: Lexchin
authors.forename: Lorraine E
authors.initials: LE
authors.lastname: Ferris
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.forename: Sunila R
authors.initials: SR
authors.lastname: Kalkar
authors.forename: Marleen
authors.initials: M
authors.lastname: Van Laethem
authors.forename: Andrea
authors.initials: A
authors.lastname: Gruneir
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gold
authors.forename: James
authors.initials: J
authors.lastname: Maskalyk
authors.forename: David L
authors.initials: DL
authors.lastname: Streiner
authors.forename: Nathan
authors.initials: N
authors.lastname: Taback
authors.forename: An-Wen
authors.initials: AW
authors.lastname: Chan
mesh_terms: D015982:Bias; D002170:Canada; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics / Q000592:standards; D003219:Confidentiality; D016265:Conflict of Interest / Q000191:economics*; D034742:Electronic Mail; D019317:Evidence-Based Medicine / Q000191:economics / Q000941:ethics; D019983:Guideline Adherence; D017408:Guidelines as Topic; D019981:Health Care Sector / Q000191:economics* / Q000941:ethics; D006801:Humans; D012042:Registries; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic / Q000941:ethics; D011795:Surveys and Questionnaires; D014342:Truth Disclosure