Jeffrey Peppercorn is a member of the Speakers Bureau for Genentech and is a consultant for Merck.
Association between pharmaceutical involvement and outcomes in breast cancer clinical trials†
Article first published online: 26 FEB 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 7, pages 1239–1246, April 2007
How to Cite
Peppercorn, J., Blood, E., Winer, E. and Partridge, A. (2007), Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer, 109: 1239–1246. doi: 10.1002/cncr.22528
Presented as Abstract 6057 at the Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, Florida.
- Issue published online: 19 MAR 2007
- Article first published online: 26 FEB 2007
- Manuscript Accepted: 14 DEC 2006
- Manuscript Revised: 11 DEC 2006
- Manuscript Received: 18 OCT 2006
- breast cancer;
- clinical trials;
- pharmaceutical industry
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.
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.
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).
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. Cancer 2007;109:. © 2007 American Cancer Society.