title: Trial sponsorship and self-reported conflicts of interest in breast cancer radiation therapy: An analysis of prospective clinical trials.
abstract: OBJECTIVE
  We aim to assess any association between study and self-reported conflict of interest (COI) or trial sponsorship in breast cancer radiation clinical trials.
  
  
  METHODS
  We searched PubMed for all clinical trials (CTs) published between 09/2004 and 09/2014 related to breast cancer. We included only radiotherapy CTs with primary clinical endpoints. We classified eligible trials according to the funding source, presence or absence of conflict of interest, study conclusion and impact factor (IF).
  
  
  RESULTS
  1,603 CTs were retrieved. 72 randomized clinical trials were included for analysis. For-profit (PO), not for profit organization (nPO), none and not reported sponsorship rates were 9/72 (12.5%), 35/72 (48.6%), 1/72 (1.4%), 27/72 (37.5%), respectively. Present, absent or not reported COI were found in 6/72 (8.3%), 43/72 (59.7%) and 23/72 (32%) of the CTs, respectively. Conclusion was positive, neutral and negative in 57/72 (79.1%), 9/72 (12.5%) and 6/72 (8.4%) of the trials, respectively. Positive conclusion was reported in 33/44 (75%) funded trials (PO and nPO) and 5/6 (83.3%) CTs with reported COI. On univariate analysis no association with funding source (P=0.178), COI (P=0.678) or trial region (P=0.567) and trial positive conclusion was found. Sponsored trials (HR 4.50, 95CI-0.1.23-16.53;P=0.0023) and positive trials (HR 4.78, 95CI- 1.16-19.63;P=0.030) were more likely to be published in higher impact factor journals in the multivariate analysis.
  
  
  CONCLUSIONS
  nPO funding was reported in almost 50% of the evaluated CTs. No significant association between study conclusion and funding source, COI or trial region was identified. Sponsored trials and positive trials were more likely to be published in higher impact factor journals.
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil; Department of Radiology and Oncology of University of São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil. Electronic address: eltontt@gmail.com.
authors.forename: Elton T T
authors.initials: ETT
authors.lastname: Leite
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON M5G 2M9, Canada. Electronic address: fymoraes@gmail.com.
authors.forename: Fabio Y
authors.initials: FY
authors.lastname: Moraes
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil; Department of Radiology and Oncology of University of São Paulo, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil. Electronic address: gustavo.marta@hc.fm.usp.br.
authors.forename: Gustavo N
authors.initials: GN
authors.lastname: Marta
authors.affiliation: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Electronic address: neil.taunk@gmail.com.
authors.forename: Neil K
authors.initials: NK
authors.lastname: Taunk
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil. Electronic address: marinalannes@hotmail.com.
authors.forename: Marina T L
authors.initials: MTL
authors.lastname: Vieira
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil. Electronic address: samir.hanna@hsl.org.br.
authors.forename: Samir A
authors.initials: SA
authors.lastname: Hanna
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil. Electronic address: jluis@hsl.org.br.
authors.forename: João Luis F
authors.initials: JLF
authors.lastname: Silva
authors.affiliation: Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jafet 91, Sao Paulo, SP 01308-050, Brazil; Department of Radiology and Oncology - Instituto de Radiologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo), São Paulo, Brazil. Electronic address: heloisa.carvalho@hc.fm.usp.br.
authors.forename: Heloisa A
authors.initials: HA
authors.lastname: Carvalho
mesh_terms: D001943:Breast Neoplasms / Q000532:radiotherapy*; D016265:Conflict of Interest; D005260:Female; D006801:Humans; D055811:Journal Impact Factor; D015999:Multivariate Analysis; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000941:ethics*; D012109:Research Support as Topic / Q000941:ethics*
keywords: Breast cancer; Conflicts of interest; Funding; Radiotherapy; Sponsorship