title: Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.
abstract: OBJECTIVE
  To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.
  
  
  METHODS
  Cross sectional study of randomized controlled trials (RCTs).
  
  
  METHODS
  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.
  
  
  METHODS
  Random sample of RCTs focused on drug efficacy.
  
  
  METHODS
  Association between financial ties of principal investigators and study outcome.
  
  
  RESULTS
  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).
  
  
  CONCLUSIONS
  Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.
authors.affiliation: Oregon Health and Science University, Portland, OR 97239, USA.
authors.forename: Rosa
authors.initials: R
authors.lastname: Ahn
authors.affiliation: San Francisco VA Medical Center, San Francisco, CA 94121, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Woodbridge
authors.affiliation: San Francisco VA Medical Center, San Francisco, CA 94121, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Abraham
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA 94304, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Saba
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Korenstein
authors.affiliation: San Francisco VA Medical Center, San Francisco, CA 94121, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Madden
authors.affiliation: San Francisco VA Medical Center, San Francisco, CA 94121, USA.|University of California, San Francisco, San Francisco, CA 94121, USA.
authors.forename: W John
authors.initials: WJ
authors.lastname: Boscardin
authors.affiliation: San Francisco VA Medical Center, San Francisco, CA 94121, USA salomeh.keyhani@ucsf.edu.|University of California, San Francisco, San Francisco, CA 94121, USA.
authors.forename: Salomeh
authors.initials: S
authors.lastname: Keyhani
mesh_terms: D016265:Conflict of Interest / Q000191:economics; D003430:Cross-Sectional Studies; D004345:Drug Industry / Q000191:economics*; D032984:Ethics, Research; D006801:Humans; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic / Q000191:economics*; D012108:Research Personnel / Q000191:economics*; D012109:Research Support as Topic / Q000191:economics*