Literature DB >> 29869023

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

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.   

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.

Entities:  

Keywords:  Central nervous system Neoplasm; Conflict of interest; Glioma; Metastases; Oncology; Treatment

Mesh:

Year:  2018        PMID: 29869023     DOI: 10.1007/s11060-018-2860-2

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


  23 in total

1.  The association between funding by commercial interests and study outcome in randomized controlled drug trials.

Authors:  J Yaphe; R Edman; B Knishkowy; J Herman
Journal:  Fam Pract       Date:  2001-12       Impact factor: 2.267

2.  The uncertainty principle and industry-sponsored research.

Authors:  B Djulbegovic; M Lacevic; A Cantor; K K Fields; C L Bennett; J R Adams; N M Kuderer; G H Lyman
Journal:  Lancet       Date:  2000-08-19       Impact factor: 79.321

Review 3.  The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication.

Authors:  Gisela Schott; Henry Pachl; Ulrich Limbach; Ursula Gundert-Remy; Klaus Lieb; Wolf-Dieter Ludwig
Journal:  Dtsch Arztebl Int       Date:  2010-04-30       Impact factor: 5.594

4.  Disclosure of conflicts of interest by authors of clinical trials and editorials in oncology.

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

5.  Conflict of Interest: Why Does It Matter?

Authors:  Harvey V Fineberg
Journal:  JAMA       Date:  2017-05-02       Impact factor: 56.272

6.  Biomedical research in an age of austerity.

Authors:  Hamilton Moses; E Ray Dorsey
Journal:  JAMA       Date:  2012-12-12       Impact factor: 56.272

7.  The calculus of national medical research policy--the United States versus Asia.

Authors:  Gordon H Sun; Jeffrey D Steinberg; Reshma Jagsi
Journal:  N Engl J Med       Date:  2012-08-23       Impact factor: 91.245

8.  Source of funding and outcome of clinical trials.

Authors:  R A Davidson
Journal:  J Gen Intern Med       Date:  1986 May-Jun       Impact factor: 5.128

9.  Funding of US biomedical research, 2003-2008.

Authors:  E Ray Dorsey; Jason de Roulet; Joel P Thompson; Jason I Reminick; Ashley Thai; Zachary White-Stellato; Christopher A Beck; Benjamin P George; Hamilton Moses
Journal:  JAMA       Date:  2010-01-13       Impact factor: 56.272

Review 10.  Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

Authors:  Nikola Cihoric; Alexandros Tsikkinis; Giuseppe Minniti; Frank J Lagerwaard; Ulrich Herrlinger; Etienne Mathier; Ivan Soldatovic; Branislav Jeremic; Pirus Ghadjar; Olgun Elicin; Kristina Lössl; Daniel M Aebersold; Claus Belka; Evelyn Herrmann; Maximilian Niyazi
Journal:  Radiat Oncol       Date:  2017-01-03       Impact factor: 3.481

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  1 in total

1.  Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary.

Authors:  Kinga Amália Sándor-Bajusz; Andrea Kraut; Odgerel Baasan; Gergely Márovics; Károly Berényi; Szimonetta Lohner
Journal:  Trials       Date:  2022-04-21       Impact factor: 2.728

  1 in total

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