Literature DB >> 29164521

Funding source, conflict of interest and positive conclusions in neuro-oncology clinical trials.

Fabio Y Moraes1,2, Lucas C Mendez3, Neil K Taunk4, Srinivas Raman5,3, John H Suh6, Luis Souhami7, Ben Slotman8, Eduardo Weltman9,10, Daniel E Spratt11, Alejandro Berlin5, Gustavo N Marta12,13.   

Abstract

We aimed to test any association between authors' conclusions and self-reported COI or funding sources in central nervous system (CNS) studies. A review was performed for CNS malignancy clinical trials published in the last 5 years. Two investigators independently classified study conclusions according to authors' endorsement of the experimental therapy. Statistical models were used to test for associations between positive conclusions and trials characteristics. From February 2010 to February 2015, 1256 articles were retrieved; 319 were considered eligible trials. Positive conclusions were reported in 56.8% of trials with industry-only, 55.6% with academia-only, 44.1% with academia and industry, 77.8% with none, and 76.4% with not described funding source (p = 0.011). Positive conclusions were reported in 60.4% of trials with unrelated COI, 60% with related COI, and 60% with no COI reported (p = 0.997). Factors that were significantly associated with the presence of positive conclusion included trials design (phase 1) [OR 11.64 (95 CI 4.66-29.09), p < 0.001], geographic location (outside North America or Europe) [OR 1.96 (95 CI 1.05-3.79), P = 0.025], primary outcomes (non-overall or progression free survival) [OR 3.74 (95 CI 2.27-6.18), p < 0.001], and failure to disclose funding source [OR 2.45 (95 CI 1.22-5.22), p = 0.011]. In a multivariable regression model, all these factors remained significantly associated with trial's positive conclusion. Funding source and self-reported COI did not appear to influence the CNS trials conclusion. Funding source information and COI disclosure were under-reported in 14.1 and 17.2% of the CNS trials. Continued efforts are needed to increase rates of both COI and funding source reporting.

Entities:  

Keywords:  Central nervous system neoplasm; Conflict of interest; Glioma; Metastasis; Oncology; Treatment

Mesh:

Year:  2017        PMID: 29164521     DOI: 10.1007/s11060-017-2687-2

Source DB:  PubMed          Journal:  J Neurooncol        ISSN: 0167-594X            Impact factor:   4.130


  27 in total

1.  Practice guidelines developed by specialty societies: the need for a critical appraisal.

Authors:  R Grilli; N Magrini; A Penna; G Mura; A Liberati
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Review 3.  Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

Authors:  Justin E Bekelman; Yan Li; Cary P Gross
Journal:  JAMA       Date:  2003 Jan 22-29       Impact factor: 56.272

4.  Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials.

Authors:  Mohit Bhandari; Jason W Busse; Dianne Jackowski; Victor M Montori; Holger Schünemann; Sheila Sprague; Derek Mears; Emil H Schemitsch; Dianne Heels-Ansdell; P J Devereaux
Journal:  CMAJ       Date:  2004-02-17       Impact factor: 8.262

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Authors:  Rachel P Riechelmann; Lisa Wang; Aoife O'Carroll; Monika K Krzyzanowska
Journal:  J Clin Oncol       Date:  2007-10-10       Impact factor: 44.544

6.  Self-reported conflicts of interest of authors, trial sponsorship, and the interpretation of editorials and related phase III trials in oncology.

Authors:  Giovanni M Bariani; Anezka C R de Celis Ferrari; Paulo M Hoff; Monika K Krzyzanowska; Rachel P Riechelmann
Journal:  J Clin Oncol       Date:  2013-04-29       Impact factor: 44.544

7.  Understanding financial conflicts of interest.

Authors:  D F Thompson
Journal:  N Engl J Med       Date:  1993-08-19       Impact factor: 91.245

8.  Risks and benefits of phase 1 oncology trials, 1991 through 2002.

Authors:  Elizabeth Horstmann; Mary S McCabe; Louise Grochow; Seiichiro Yamamoto; Larry Rubinstein; Troy Budd; Dale Shoemaker; Ezekiel J Emanuel; Christine Grady
Journal:  N Engl J Med       Date:  2005-03-03       Impact factor: 91.245

9.  Ethics of phase 1 oncology studies: reexamining the arguments and data.

Authors:  Manish Agrawal; Ezekiel J Emanuel
Journal:  JAMA       Date:  2003-08-27       Impact factor: 56.272

10.  Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

Authors:  Rosa Ahn; Alexandra Woodbridge; Ann Abraham; Susan Saba; Deborah Korenstein; Erin Madden; W John Boscardin; Salomeh Keyhani
Journal:  BMJ       Date:  2017-01-17
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  1 in total

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

Authors:  Srinivas Raman; Fabio Y Moraes; Lucas C Mendez; Neil K Taunk; John H Suh; Luis Souhami; Ben Slotman; Paul Kongkham; Daniel E Spratt; Alejandro Berlin; Gustavo N Marta
Journal:  J Neurooncol       Date:  2018-06-04       Impact factor: 4.130

  1 in total

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