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The relationship of study and authorship characteristics on trial sponsorship and self-reported conflicts of interest among neuro-oncology clinical trials

  • Clinical Study
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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.

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Author information

Author notes

  1. Srinivas Raman and Fabio Y. Moraes have contributed equally as first authors.

Authors and Affiliations

  1. Department of Radiation Oncology, University of Toronto/Princess Margaret Hospital, 700 University Avenue, Toronto, ON, M5G 2M9, Canada

    Srinivas Raman, Fabio Y. Moraes & Alejandro Berlin

  2. Department of Radiation Oncology, University of Toronto/Sunnybrook Odette Cancer Centre, Toronto, ON, Canada

    Srinivas Raman & Lucas C. Mendez

  3. Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA

    Neil K. Taunk

  4. Department of Radiation Oncology, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Taussig Cancer Institute, Cleveland, OH, USA

    John H. Suh

  5. Department of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada

    Luis Souhami

  6. Department of Radiation Oncology, Vrije Universiteit Medical Center (VUmc), Amsterdam, The Netherlands

    Ben Slotman

  7. Department of Neursurgery, University of Toronto/Toronto Western Hospital, Toronto, ON, Canada

    Paul Kongkham

  8. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA

    Daniel E. Spratt

  9. Department of Radiation Oncology, Hospital Sírio-Libânes, São Paulo, Brazil

    Gustavo N. Marta

  10. Division of Radiation Oncology, Department of Radiology and Oncology, Faculdade de Medicina da, Universidade de São Paulo, São Paulo, Brazil

    Gustavo N. Marta

Authors
  1. Srinivas Raman
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  2. Fabio Y. Moraes
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  3. Lucas C. Mendez
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  4. Neil K. Taunk
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  5. John H. Suh
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  6. Luis Souhami
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  7. Ben Slotman
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  8. Paul Kongkham
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  9. Daniel E. Spratt
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  10. Alejandro Berlin
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  11. Gustavo N. Marta
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Corresponding author

Correspondence to Fabio Y. Moraes.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Raman, S., Moraes, F.Y., Mendez, L.C. et al. The relationship of study and authorship characteristics on trial sponsorship and self-reported conflicts of interest among neuro-oncology clinical trials. J Neurooncol 139, 195–203 (2018). https://doi.org/10.1007/s11060-018-2860-2

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  • DOI: https://doi.org/10.1007/s11060-018-2860-2

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