Association between pharmaceutical involvement and outcomes in breast cancer clinical trials.
Abstract
BACKGROUND: Since 1992, pharmaceutical industry support has surpassed National Institutes of Health funding for clinical research in the United States. In this study, the authors sought to evaluate the impact of this shift in funding from public to private sponsors on the nature of published breast cancer clinical research. METHODS: All published breast cancer clinical trials from 2003, 1998, and 1993 were reviewed from 10 select English-language medical journals to evaluate pharmaceutical involvement over time and the association between sponsorship, trial design, and results. Clinical studies that reported disease-specific outcomes from medical therapy for breast cancer were eligible for analysis. Pharmaceutical involvement was defined as reported pharmaceutical industry funding, provision of drug, and/or authorship for each publication. RESULTS: In total, 140 eligible studies were identified, including 45 studies that were published in 1993, 39 studies that were published in 1998, and 56 studies that were published in 2003. Among those, 67 publications (48%) reported pharmaceutical industry involvement, 36 publications (26%) had at least >/=1 pharmaceutical industry author, And 100 publications (71%) were considered positive. Pharmaceutical involvement was identified in 44% of the studies published in 1993, in 38% of the studies published in 1998, and in 58% of the studies published in 2003. Pharmaceutical authorship was reported in 22% of the 1993 studies, in 21% of the 1998 studies, and in 34% of the 2003 studies. For studies that were published in 2003, those that reported pharmaceutical involvement were more likely to be positive (84% vs 54%; P = .02; Fisher exact test), to be single-arm studies (66% vs 33%; P = .03), and to evaluate metastatic disease (72% vs 46%; P = .06). CONCLUSIONS: Pharmaceutical involvement in published clinical breast cancer research may affect study design, focus, and results. Further research is warranted, including analysis of unpublished studies, to evaluate the impact of increasing pharmaceutical industry involvement on clinical research.
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Outcomes of reports of randomized trials and meta-analyses of clinical trials funded by the pharmaceutical industry are more likely to favor the sponsor's product compared to studies with other sources of funding.
“Lexchin and colleagues [166] observed that outcomes of reports of randomized trials and meta-analyses of clinical trials funded by the pharmaceutical industry are more likely to favor the sponsor's product compared to studies with other sources of funding.”
From The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration (2009) · cites this paper as [168]
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- Authors
- Peppercorn, J., Blood, E., Winer, E., & Partridge, A.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Dana-Farber Cancer Institute (US)
- Sanofi (France) (FR)
- Corresponding author
- Peppercorn, Jeffrey
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2007-02-26
- Volume
- 109
- Issue
- 7
- Pages
- 1239-1246
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W2052494740
- Cited by
- 123
- References
- 26
- Citations by year
- 2025: 5 · 2024: 2 · 2023: 6 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 4 · 2018: 5 · 2017: 5 · 2016: 5 · 2015: 7 · 2014: 8 · 2013: 7 · 2012: 8
- FWCI
- 11.63
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Social Sciences › Business, Management and Accounting › Organizational Behavior and Human Resource Management › Global Public Health Policies and Epidemiology
- Social Sciences › Business, Management and Accounting › Strategy and Management › Political Influence and Corporate Strategies
- Keywords
- pharmaceutical industry sponsorship, breast cancer clinical trials, conflicts of interest, trial design, single-arm studies, metastatic breast cancer, research funding sources
- MeSH terms
- Antineoplastic Agents, Authorship, Breast Neoplasms, Clinical Trials as Topic, Drug Evaluation, Drug Industry, Humans, Publishing, Research Support as Topic, Treatment Outcome, Biomedical Research
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