Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
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Ariadna Tibau1, Geòrgia Anguera1, Fernando Andrés-Pretel2, Arnoud J. Templeton3, Bostjan Seruga4, Agustí Barnadas1, Eitan Amir5 and Alberto Ocana6
1Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain
2Research Foundation of the Paraplegics Hospital of Toledo, Toledo, Spain
3Department of Medical Oncology, St Claraspital, Basel and Faculty of Medicine, University of Basel, Basel, Switzerland
4Department of Medical Oncology, Institute of Oncology Ljubljana and University of Ljubljana, Ljubljana, Slovenia
5Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada
6Translational Research Unit, Albacete University Hospital, Centro Regional de Investigaciones Biomédicas, Universidad de Castilla La Mancha, CIBERONC, Albacete, Spain
Ariadna Tibau, email: [email protected]
Keywords: funding source; sponsorship; cooperative groups; pharmaceutical industry; government or academic institutions
Received: November 08, 2017 Accepted: February 21, 2018 Epub: February 28, 2018 Published: March 13, 2018
Introduction: 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.
Results: 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).
Materials and Methods: 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.
Conclusions: 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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