Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Tibau, Ariadna, Anguera, Geòrgia, Andrés-Pretel, Fernando, Templeton, Arnoud J., Seruga, Bostjan, Barnadas, Agustí, Amir, Eitan, Ocana, Alberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Impact Journals LLC 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871097/
https://www.ncbi.nlm.nih.gov/pubmed/29599926
http://dx.doi.org/10.18632/oncotarget.24589
_version_ 1783309600168083456
author Tibau, Ariadna
Anguera, Geòrgia
Andrés-Pretel, Fernando
Templeton, Arnoud J.
Seruga, Bostjan
Barnadas, Agustí
Amir, Eitan
Ocana, Alberto
author_facet Tibau, Ariadna
Anguera, Geòrgia
Andrés-Pretel, Fernando
Templeton, Arnoud J.
Seruga, Bostjan
Barnadas, Agustí
Amir, Eitan
Ocana, Alberto
author_sort Tibau, Ariadna
collection PubMed
description 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.
format Online
Article
Text
id pubmed-5871097
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Impact Journals LLC
record_format MEDLINE/PubMed
spelling pubmed-58710972018-03-29 Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer Tibau, Ariadna Anguera, Geòrgia Andrés-Pretel, Fernando Templeton, Arnoud J. Seruga, Bostjan Barnadas, Agustí Amir, Eitan Ocana, Alberto Oncotarget Research Paper 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. Impact Journals LLC 2018-02-28 /pmc/articles/PMC5871097/ /pubmed/29599926 http://dx.doi.org/10.18632/oncotarget.24589 Text en Copyright: © 2018 Tibau et al. http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/) 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Paper
Tibau, Ariadna
Anguera, Geòrgia
Andrés-Pretel, Fernando
Templeton, Arnoud J.
Seruga, Bostjan
Barnadas, Agustí
Amir, Eitan
Ocana, Alberto
Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title_full Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title_fullStr Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title_full_unstemmed Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title_short Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
title_sort role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871097/
https://www.ncbi.nlm.nih.gov/pubmed/29599926
http://dx.doi.org/10.18632/oncotarget.24589
work_keys_str_mv AT tibauariadna roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT anguerageorgia roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT andrespretelfernando roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT templetonarnoudj roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT serugabostjan roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT barnadasagusti roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT amireitan roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer
AT ocanaalberto roleofcooperativegroupsandfundingsourceinclinicaltrialssupportingguidelinesforsystemictherapyofbreastcancer