Srinivas Raman1,2, Fabio Y Moraes3, Lucas C Mendez2, Neil K Taunk4, John H Suh5, Luis Souhami6, Ben Slotman7, Paul Kongkham8, Daniel E Spratt9, Alejandro Berlin1, Gustavo N Marta10,11. 1. Department of Radiation Oncology, University of Toronto/Princess Margaret Hospital, 700 University Avenue, Toronto, ON, M5G 2M9, Canada. 2. Department of Radiation Oncology, University of Toronto/Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. 3. Department of Radiation Oncology, University of Toronto/Princess Margaret Hospital, 700 University Avenue, Toronto, ON, M5G 2M9, Canada. fymoraes@gmail.com. 4. Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA. 5. Department of Radiation Oncology, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Taussig Cancer Institute, Cleveland, OH, USA. 6. Department of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada. 7. Department of Radiation Oncology, Vrije Universiteit Medical Center (VUmc), Amsterdam, The Netherlands. 8. Department of Neursurgery, University of Toronto/Toronto Western Hospital, Toronto, ON, Canada. 9. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. 10. Department of Radiation Oncology, Hospital Sírio-Libânes, São Paulo, Brazil. 11. Division of Radiation Oncology, Department of Radiology and Oncology, Faculdade de Medicina da, Universidade de São Paulo, São Paulo, Brazil.
Abstract
PROPOSE: To examine the association between trial sponsorship sources, self-reported conflicts of interest (COI), and study and author characteristics in central nervous system (CNS) oncology clinical trials (CT). METHODS: MEDLINE search was performed for original CT on "Central Nervous System Neoplasms"[Mesh]. The investigators assessed for relationships between funding source (industry, academic or cooperative, none, not described), COI (presented, none, or not reported), CT, and author characteristics. RESULTS: From 2010 to 2015, 319 CT were considered eligible. The majority of the studies involved primary gliomas (55.2%) and were Phase II CT (59.2%). Drug therapy was investigated in 83.0% of the CT. The remaining studies investigated surgery or radiotherapy. A minority of papers were published in journals with impact factor (IF) higher than > 10 (16%) or in regions other than North America and Europe (20.4%). Overall, 83.1% of studies disclosed funding sources: 32.6% from industry alone, 33.9% from an academic or cooperative group, and 10.7% from a mixed funding model. COI data was reported by 85.9% of trials, of which 56.2% reported no COI and 43.8% reported a related COI. Significant predictors for sponsorship (industry and/or academia) on univariate analysis were study design, type of intervention, journal impact factor, study conclusion, transparency of COI and presence of COI. On multivariate analysis, type of intervention, (P < 0.001), journal impact factor (IF) (P = 0.003), presence of COI (P < 0.001) and study conclusion (P = 0.003) remained significant predictors of sponsorship. For predicting COI, significant variables on univariate analysis were disease type, type of intervention, journal IF, funding source, and intervention arm being related to sponsor. On multivariate analysis, disease type (P = 0.003), journal IF (P < 0.001), type of intervention (P = 0.001), and funding source (P = 0.008) remained significant. CONCLUSIONS: The majority of CNS CT reported some external funding sources and non-related COI. We identified that drug trials, higher IF, presence of COI, and a neutral or negative study conclusion are associated with external funding. Likewise drug trials, higher IF, and glioma trials are associated with presence of COI.
PROPOSE: To examine the association between trial sponsorship sources, self-reported conflicts of interest (COI), and study and author characteristics in central nervous system (CNS) oncology clinical trials (CT). METHODS: MEDLINE search was performed for original CT on "Central Nervous System Neoplasms"[Mesh]. The investigators assessed for relationships between funding source (industry, academic or cooperative, none, not described), COI (presented, none, or not reported), CT, and author characteristics. RESULTS: From 2010 to 2015, 319 CT were considered eligible. The majority of the studies involved primary gliomas (55.2%) and were Phase II CT (59.2%). Drug therapy was investigated in 83.0% of the CT. The remaining studies investigated surgery or radiotherapy. A minority of papers were published in journals with impact factor (IF) higher than > 10 (16%) or in regions other than North America and Europe (20.4%). Overall, 83.1% of studies disclosed funding sources: 32.6% from industry alone, 33.9% from an academic or cooperative group, and 10.7% from a mixed funding model. COI data was reported by 85.9% of trials, of which 56.2% reported no COI and 43.8% reported a related COI. Significant predictors for sponsorship (industry and/or academia) on univariate analysis were study design, type of intervention, journal impact factor, study conclusion, transparency of COI and presence of COI. On multivariate analysis, type of intervention, (P < 0.001), journal impact factor (IF) (P = 0.003), presence of COI (P < 0.001) and study conclusion (P = 0.003) remained significant predictors of sponsorship. For predicting COI, significant variables on univariate analysis were disease type, type of intervention, journal IF, funding source, and intervention arm being related to sponsor. On multivariate analysis, disease type (P = 0.003), journal IF (P < 0.001), type of intervention (P = 0.001), and funding source (P = 0.008) remained significant. CONCLUSIONS: The majority of CNS CT reported some external funding sources and non-related COI. We identified that drug trials, higher IF, presence of COI, and a neutral or negative study conclusion are associated with external funding. Likewise drug trials, higher IF, and glioma trials are associated with presence of COI.
Entities:
Keywords:
Central nervous system Neoplasm; Conflict of interest; Glioma; Metastases; Oncology; Treatment
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