title: Impact of industry collaboration on randomised controlled trials in oncology.
abstract: Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT).
  
  
  
  We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding.
  
  
  
  We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p < 0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04-1·67], p = 02), and blinding of patients (RR 3·05, 95% CI [1·71-5·44], p < 0001), clinicians (RR 3·36, 95% CI [1·83-6·16], p≤·001) and outcomes assessors (RR 3·03, 95% CI [1·57-5·83], p = 0002). They did not differ in use of overall survival as a primary end-point (RR 1·27 95% CI [0·72-2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85-1·46], p = 0.45). Studies with funding only did not differ from those without funding.
  
  
  
  Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias.
authors.affiliation: University of California San Francisco, 631 Diamond Street, San Francisco, CA 94114, USA. Electronic address: Anne.linker@ucsf.edu.
authors.forename: Anne
authors.initials: A
authors.lastname: Linker
authors.affiliation: Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY 10017, USA. Electronic address: yanga1@mskcc.org.
authors.forename: Annie
authors.initials: A
authors.lastname: Yang
authors.affiliation: National Institutes of Health/National Cancer Institute, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: Nitin.roper@nih.gov.
authors.forename: Nitin
authors.initials: N
authors.lastname: Roper
authors.affiliation: Library and Center for Knowledge Management, University of California San Francisco, 530 Parnassus Avenue, San Francisco, CA 94143, USA. Electronic address: Evans.whitaker@ucsf.edu.
authors.forename: Evans
authors.initials: E
authors.lastname: Whitaker
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY 10017, USA. Electronic address: korenstd@mskcc.org.
authors.forename: Deborah
authors.initials: D
authors.lastname: Korenstein
mesh_terms: D002202:Capital Financing; D016265:Conflict of Interest; D004345:Drug Industry; D006801:Humans; D057194:Intention to Treat Analysis / Q000706:statistics & numerical data; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D010919:Placebos
keywords: Collaboration; Conflict of interest; Disclosure; Drug industry; Randomised controlled trials