title: Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials.
abstract: OBJECTIVE
  To evaluate the association of financial conflicts of interest (FCOI) with the characteristics, outcome and reported methodological quality of fibromyalgia drug therapy randomized controlled trials (FM-RCTs).
  
  
  METHODS
  A cross-sectional study of original, parallel-group, drug therapy FM-RCTs published between 1997 and 2011 from Medline and Cochrane Central Register of Controlled Trials was conducted. Two reviewers independently assessed each RCT for funding source, authors' FCOI(s), study characteristics, reporting of methodological measures important for internal validity and outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or non-positive).
  
  
  RESULTS
  Forty-seven RCTs were eligible with funding source as: 26 (55.3%) industry; eight (17%) non-profit source(s); five (10.6%) mixed; and eight (17%) unspecified. Industry-funded RCTs were more likely to be multicenter and enroll greater number of patients. Reporting of key methodological measures was suboptimal; however, industry and non-profit funded RCTs did not differ in their reporting. Thirty (63.8%) RCTs had ≥ one author who disclosed an FCOI (receipt of research grant [21, 44.7%], industry sponsor employee [20, 42.6%], receipt of consultancy fee/honorarium [16, 34%] and stock ownership [11, 23.4%]). Although industry funding and certain authors' FCOIs (employment and receipt of consultancy fee/honorarium) were univariately associated with positive outcome, such association was not observed after adjusting for study sample size.
  
  
  CONCLUSIONS
  The majority of FM-RCTs were industry-sponsored, and had at least one author with an FCOI. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author's FCOI with study outcome was seen.
authors.affiliation: University of Southern California-Los Angeles County Medical Center, Los Angeles, CA, USA.
authors.forename: Winnie K
authors.initials: WK
authors.lastname: Pang
authors.affiliation: University of Southern California-Los Angeles County Medical Center, Los Angeles, CA, USA.
authors.forename: Karen C
authors.initials: KC
authors.lastname: Yeter
authors.affiliation: Loma Linda University, Loma Linda, CA, USA.
authors.forename: Karina D
authors.initials: KD
authors.lastname: Torralba
authors.affiliation: University of Arkansas for Medical Sciences, Little Rock, AR, USA.
authors.forename: Horace J
authors.initials: HJ
authors.lastname: Spencer
authors.affiliation: Central Arkansas Veterans Healthcare System, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
authors.forename: Nasim A
authors.initials: NA
authors.lastname: Khan
mesh_terms: D000700:Analgesics / Q000191:economics* / Q000627:therapeutic use*; D016265:Conflict of Interest / Q000191:economics*; D016527:Drug Costs; D004345:Drug Industry / Q000191:economics* / Q000941:ethics; D005356:Fibromyalgia / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D009939:Organizations, Nonprofit / Q000191:economics* / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000941:ethics; D012109:Research Support as Topic / Q000191:economics* / Q000941:ethics; D016896:Treatment Outcome
chemical_list: D000700:Analgesics
keywords: clinical trials; evidence-based medicine; fibromyalgia; pain