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Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials

OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs) conducted by G...

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Autores principales: Djulbegovic, Benjamin, Kumar, Ambuj, Miladinovic, Branko, Reljic, Tea, Galeb, Sanja, Mhaskar, Asmita, Mhaskar, Rahul, Hozo, Iztok, Tu, Dongsheng, Stanton, Heather A., Booth, Christopher M., Meyer, Ralph M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3605423/
https://www.ncbi.nlm.nih.gov/pubmed/23555593
http://dx.doi.org/10.1371/journal.pone.0058711
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author Djulbegovic, Benjamin
Kumar, Ambuj
Miladinovic, Branko
Reljic, Tea
Galeb, Sanja
Mhaskar, Asmita
Mhaskar, Rahul
Hozo, Iztok
Tu, Dongsheng
Stanton, Heather A.
Booth, Christopher M.
Meyer, Ralph M.
author_facet Djulbegovic, Benjamin
Kumar, Ambuj
Miladinovic, Branko
Reljic, Tea
Galeb, Sanja
Mhaskar, Asmita
Mhaskar, Rahul
Hozo, Iztok
Tu, Dongsheng
Stanton, Heather A.
Booth, Christopher M.
Meyer, Ralph M.
author_sort Djulbegovic, Benjamin
collection PubMed
description OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs) conducted by GlaxoSmithKline (GSK) and the NCIC Clinical Trials Group (CTG). We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1) the proportion of statistically significant trials favouring the experimental treatment, (2) the proportion of the trials in which new treatments were considered superior according to the investigators, and (3) quantitative synthesis of data for primary outcomes as defined in each trial. RESULTS: GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60) of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37) in the CTG cohort (RR = 1.68; p = 0.04). Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001). Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47–0.78] compared to 0.86 [0.74–1.00]; p = 0.003). However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade. CONCLUSIONS: While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time.
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spelling pubmed-36054232013-04-03 Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials Djulbegovic, Benjamin Kumar, Ambuj Miladinovic, Branko Reljic, Tea Galeb, Sanja Mhaskar, Asmita Mhaskar, Rahul Hozo, Iztok Tu, Dongsheng Stanton, Heather A. Booth, Christopher M. Meyer, Ralph M. PLoS One Research Article OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs) conducted by GlaxoSmithKline (GSK) and the NCIC Clinical Trials Group (CTG). We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1) the proportion of statistically significant trials favouring the experimental treatment, (2) the proportion of the trials in which new treatments were considered superior according to the investigators, and (3) quantitative synthesis of data for primary outcomes as defined in each trial. RESULTS: GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60) of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37) in the CTG cohort (RR = 1.68; p = 0.04). Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001). Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47–0.78] compared to 0.86 [0.74–1.00]; p = 0.003). However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade. CONCLUSIONS: While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time. Public Library of Science 2013-03-21 /pmc/articles/PMC3605423/ /pubmed/23555593 http://dx.doi.org/10.1371/journal.pone.0058711 Text en © 2013 Djulbegovic et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Djulbegovic, Benjamin
Kumar, Ambuj
Miladinovic, Branko
Reljic, Tea
Galeb, Sanja
Mhaskar, Asmita
Mhaskar, Rahul
Hozo, Iztok
Tu, Dongsheng
Stanton, Heather A.
Booth, Christopher M.
Meyer, Ralph M.
Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title_full Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title_fullStr Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title_full_unstemmed Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title_short Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
title_sort treatment success in cancer: industry compared to publicly sponsored randomized controlled trials
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3605423/
https://www.ncbi.nlm.nih.gov/pubmed/23555593
http://dx.doi.org/10.1371/journal.pone.0058711
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