Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer

// Ariadna Tibau 1 , Georgia Anguera 1 , Fernando Andres-Pretel 2 , Arnoud J. Templeton 3 , Bostjan Seruga 4 , Agusti Barnadas 1 , Eitan Amir 5 and Alberto Ocana 6 1 Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona, Barcelona, Spain 2 Research Foundation of the Paraplegics Hospital of Toledo, Toledo, Spain 3 Department of Medical Oncology, St Claraspital, Basel and Faculty of Medicine, University of Basel, Basel, Switzerland 4 Department of Medical Oncology, Institute of Oncology Ljubljana and University of Ljubljana, Ljubljana, Slovenia 5 Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada 6 Translational Research Unit, Albacete University Hospital, Centro Regional de Investigaciones Biomedicas, Universidad de Castilla La Mancha, CIBERONC, Albacete, Spain Correspondence to: Ariadna Tibau, email: atibau@santpau.cat 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 ABSTRACT 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.