Abstract
IntroductionClinical 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.ResultsWe 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 MethodsASCO, 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.ConclusionsIndustry 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.
Highlights
Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry
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)
We identified sponsors and/or the funding source(s) and determined whether CGs, industry, or government or academic institutions were involved
Summary
Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry. We evaluate the role of CGs and funding sources in the development of guidelines for breast cancer therapies. Clinical trials play a crucial role for the development of novel therapeutic agents in oncology [1]. Well designed clinical trials need to be adequately funded and promoted. Clinical research of systemic therapy can be sponsored through non-profit organizations mainly public resources (i.e. government or academic institutions), by pharmaceutical companies (i.e. for profit), or both. The pharmaceutical industry plays a key role in the discovery of novel drugs, the collaboration with physicians in academic institutions is essential during clinical evaluation [2]. Studies can be run directly by private companies, or be supported independently by cooperative groups (CGs) or academic centres
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
