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Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
Tibau, Ariadna (Institut d'Investigació Biomèdica Sant Pau)
Anguera, Geòrgia (Institut d'Investigació Biomèdica Sant Pau)
Andrés-Pretel, Fernando (Research Foundation of the Paraplegics Hospital of Toledo, Toledo, Spain)
Templeton, Arnoud J. (Department of Medical Oncology, St Claraspital, Basel and Faculty of Medicine, University of Basel, Basel, Switzerland)
Seruga, Bostjan (Department of Medical Oncology, Institute of Oncology Ljubljana and University of Ljubljana, Ljubljana, Slovenia)
Barnadas i Molins, Agustí (Institut d'Investigació Biomèdica Sant Pau)
Amir, Eitan (Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada)
Ocana, Alberto (Translational Research Unit, Albacete University Hospital, Centro Regional de Investigaciones Biomédicas, Universidad de Castilla La Mancha, CIBERONC, Albacete, Spain)

Date: 2018
Abstract: Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry. Here, we evaluate the role of CGs and funding sources in the development of guidelines for breast cancer therapies. We identified 94 studies. CGs were involved in 28 (30%) studies while industry either partially or fully sponsored 64 (68%) studies. The number of industry funded studies increased over time (from 0% in 1976 to 100% in 2014; p for trend = 0. 048). Only 10 (11%) government or academic studies were identified. Studies conducted by GCs included a greater number of subjects (median 448 vs. 284; p = 0. 015), were more common in the neo/adjuvant setting (p < 0. 0001), and were more often randomized (p = 0. 018) phase III (p < 0. 0001) trials. Phase III trial remained significant predictor for CG-sponsored trials (OR 7. 1 p = 0. 004) in a multivariable analysis. Industry funding was associated with higher likelihood of positive outcomes favoring the sponsored experimental arm (p = 0. 013) but this relationship was not seen for CG-sponsored trials (p = 0. 53). ASCO, ESMO, and NCCN guidelines were searched to identify systemic anti-cancer therapies for early-stage and metastatic breast cancer. Trial characteristics and outcomes were collected. We identified sponsors and/or the funding source(s) and determined whether CGs, industry, or government or academic institutions were involved. Chi-square tests were used for comparison between studies. Industry funding is present in the majority of studies providing the basis for which recommendations about treatment of breast cancer are made. Industry funding, but not CG-based funding, was associated with higher likelihood of positive outcomes in clinical studies supporting guidelines for systemic therapy.
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Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. Creative Commons
Language: Anglès.
Document: article ; publishedVersion
Subject: Funding source ; Sponsorship ; Cooperative groups ; Pharmaceutical industry ; Government or academic institutions
Published in: Oncotarget, Vol. 9 (february 2018) , p. 15061-15067, ISSN 1949-2553

DOI: 10.18632/oncotarget.24589
PMID: 29599926


7 p, 951.5 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > Institut d'Investigació Biomèdica Sant Pau
Articles > Published articles

 Record created 2018-06-18, last modified 2019-07-19



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