title: Self-reported Conflicts of Interest and Trial Sponsorship of Clinical Trials in Prostate Cancer Involving Radiotherapy.
abstract: OBJECTIVE
  To examine the association between trial sponsorship and conflicts of interest (COI) with clinical trial conclusions for prostate cancer trials related to radiotherapy.
  
  
  METHODS
  The MEDLINE database was searched for all prostate cancer clinical trials published between 2004 and 2013 and identified 1396 studies. Two investigators independently identified trials published in the English language of ≥30 patients, and extracted relevant data. Clinical trials were classified according to trial characteristics, sponsorship source and type, COI, and study conclusion, and analyzed by univariable and multivariable logistic regression.
  
  
  RESULTS
  Of 240 eligible trials, 160 (67.5%) evaluated drugs without radiotherapy, 60 (25%) involved radiotherapy, and 18 (7.5%) involved procedures without radiotherapy. Of the 60 radiotherapy trials eligible for analysis, positive sponsorship and potential COI were present in 58.3% and 20% of trials, respectively. Study conclusions were positive, negative, or neutral in 78.3%, 5%, and 16.7% of trials, respectively. No association was found between positive conclusions and either industry support of potential COI. Positive conclusions were reported in 86.7% and 83.3% of trials with sponsorship and COI, respectively, as compared with 75.6% and 77.1% of those without sponsorship (P=0.37) and COI (P=0.64). Sponsorship was significantly associated with radiotherapy trials combined with drugs (odds ratio 5.5, P=0.01) and higher-risk disease (odds ratio 4.71, P=0.01).
  
  
  CONCLUSIONS
  The presence of sponsorship was associated with radiotherapy trials involving drugs or studying higher-risk prostate cancer. However, there were no identified associations between study conclusion and sponsorship type or COI.
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.|Department of Radiology and Oncology, Instituto de Radiologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
authors.forename: Fabio Ynoe de
authors.initials: FY
authors.lastname: Moraes
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.|Department of Radiology and Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo.
authors.forename: Elton Trigo Teixeira
authors.initials: ETT
authors.lastname: Leite
authors.affiliation: Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, MI.
authors.forename: Dan A
authors.initials: DA
authors.lastname: Hamstra
authors.affiliation: Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, MI.
authors.forename: Felix Y
authors.initials: FY
authors.lastname: Feng
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.
authors.forename: Fernando Freire
authors.initials: FF
authors.lastname: Arruda
authors.affiliation: Department of Radiation Oncology, Sirio-Libanês, Hospital, Brasília, DF.
authors.forename: Rafael
authors.initials: R
authors.lastname: Gadia
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.
authors.forename: Carlos Eduardo Cintra Vita
authors.initials: CECV
authors.lastname: Abreu
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.|Department of Radiology and Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo.
authors.forename: Gustavo Nader
authors.initials: GN
authors.lastname: Marta
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.
authors.forename: Samir Abdallah
authors.initials: SA
authors.lastname: Hanna
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.
authors.forename: João Luis Fernandes da
authors.initials: JLFD
authors.lastname: Silva
authors.affiliation: Department of Radiation Oncology, Sírio-Libanês, São Paulo, Brazil.|Department of Radiology and Oncology, Instituto de Radiologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
authors.forename: Heloisa de Andrade
authors.initials: HA
authors.lastname: Carvalho
authors.affiliation: Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, MI.|Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Spratt
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic / Q000191:economics*; D016265:Conflict of Interest; D005378:Financial Support; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal / Q000191:economics* / Q000941:ethics; D014481:United States