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References Abrams, J., R. Erwin, G. Fyfe, R. L. Schilsky, and R. Temple. 2009. Data submission standards and evidence requirements. Presented at the Conference on Clinical Cancer Research, Panel 1. Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC. ACS CAN (American Cancer Society Cancer Action Network). 2009. Barriers to provider participation in clinical cancer trials: Potential policy solutions. Washington, DC: American Cancer Society Cancer Action Network. C-Change and the Coalition for Cancer Cooperative Groups. 2006. Enhancing cancer treatment through improved understanding of the critical components, economics, and barriers of cancer clinical trials. Washington, DC: C-Change; Philadelphia, PA: Coalition of Cancer Cooperative Groups. Cheng, S. K., M. Dietrich, S. Finnigan, A. Sandler, J. Crites, L. Ferranti, A. Wu, and D. Dilts. 2009. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies. Journal of Clinical Oncology 200ASCO Annual Meeting Proceedings 27(18 Suppl.):CRA6509. CTEP (Cancer Therapy Evaluation Program). 2011. CTEP intellectual property option to collaborator. Federal Register 76(48):13404-13410. Federal Register. 2011. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Volume 76, Number 143. http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm (accessed July 27, 2011). Flaherty, K. T., I. Puzanov, K. B. Kim, A. Riba, G. A. McArthur, J. A. Sosman, P. J. O’Dwyer, R. L. Lee, J. F. Grippo, K. Nolop, and P. B. Chapman. 2010. Inhibition of mutated, activated BRAF in metastatic melanoma. New England Journal of Medicine 26;363(9):809-819. Gianni, L. 2009. Anthracyclines and early breast cancer: The end of an era? Journal of Clinical Oncology 27(8):1155-1157. 91

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92 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM Hautala, J. 2010. Cooperative Group Financial, Organizational and Management Analysis. Presentation to the NCI Clinical Trials and Translational Research Advisory Committee, September 21. http://deainfo.nci.nih.gov/advisory/ctac/0910/presentations/Hautala. pdf (accessed April 21, 2011). IOM (Institute of Medicine). 2010. A national cancer clinical trials system for the 21st century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: The National Academies Press. Jones, S., F. A. Holmes , J. O’Shaughnessy, J. L. Blum, S. J. Vukelja, K. J. McIntyre, J. E. Pippen, J. H. Bordelon, R. L. Kirby, J. Sandbach, W. J. Hyman, D. A. Richards, R. G. Mennel, K. A. Boehm, W. G. Meyer, L. Asmar, D. Mackey, S. Riedel, H. Muss, and M. A. Savin. 2009. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared to doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. Journal of Clinical Oncology 27(8):1177-1183. Kanarek, N. F., H. L. Tsai, S. Metzger-Gaud, D. Damron, A. Guseynova, J. F. Klamerus, and C. M. Rudin. 2010. Geographic proximity and racial disparities in cancer clinical trial participation. Journal of the National Comprehensive Cancer Network 8(12):1343-1351. Klabunde, C. N., N. L. Keating, A. L. Potosky, A. Ambs, Y. He, M. C. Hornbrook, and P. A. Ganz. 2011. A population-based assessment of specialty physician involvement in cancer clinical trials. Journal of the National Cancer Institute 103(5):384-397. Klamerus, J. F., S. S. Bruinooge, X. Ye, M. L. Klamerus, D. Damron, D. Lansey, J. C. Lowery, L. A. Diaz, Jr., J. G. Ford, N. Kanarek, and C. M. Rudin. 2010. The impact of insurance on access to cancer clinical trials at a comprehensive cancer center. Clinical Cancer Research 16(24):5997-6003. Korn, E. L., B. Freidlin, M. Mooney, and J. S. Abrams. 2010. Accrual experience of National Cancer Institute Cooperative Group Phase III trials activated from 2000 to 2007. Journal of Clinical Oncology 28(35):5197-5201. Kwak, E. L., Y. J. Bang, D. R. Camidge, A. T. Shaw, B. Solomon, R. G. Maki, S. H. Ou, B. J. Dezube, P. A. Jänne, D. B. Costa, M. Varella-Garcia, W. H. Kim, T. J. Lynch, P. Fidias, H. Stubbs, J. A. Engelman, L. V. Sequist, W. Tan, L. Gandhi, M. Mino-Kenudson, G. C. Wei, S. M. Shreeve, M. J. Ratain, J. Settleman, J. G. Christensen, D. A. Haber, K. Wilner, R. Salgia, G. I. Shapiro, J. W. Clark, and A. J. Iafrate. 2010. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. New England Journal of Medicine 363(18):1693-1703. Moss, A. J., C. W. Francis, and D. Ryan. 2011. Collaborative clinical trials. New England Journal of Medicine 364(9):789-791. NCI (National Cancer Institute). 2005. Report of the clinical trials working group of the National Cancer Advisory Board: Restructuring the National Cancer Clinical Trials Enterprise. Bethesda, MD: National Cancer Institute. ———. 2010. Report of the operational efficiency working group of the Clinical Trials and Translational Research Advisory Committee: Compressing the timeline for cancer clinical trial activation. Bethesda, MD: National Cancer Institute. Perry, M. C., R. L. Comis, and R. L. Schilsky. 2008. Introduction: Contributions of the cooperative groups. Seminars in Oncology 35(5):459. Research!America. 2010. Research enterprise survey. http://www.researchamerica.org/uploads/ ResearchEnterprisePoll.pdf (accessed April 20, 2010).

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93 REFERENCES Schroen, A. T., G. R. Petroni, H. Wang, B. Djulbegovis, C. L., Slingluff, X. F. Wang, R. Gray, D. J. Sargent, W. Cronin, and J. Benedetti. 2009. Challenges to accrual predictions to Phase III cancer clinical trials: A survey of study chairs and lead statisticians of 248 NCI- sponsored trials. Journal of Clinical Oncology 27:15s (suppl; abstr 6562). Sood, A., K. Prasad, L. Chhatwani, E. Shinozaki, S. Cha, L. Loehrer, and D. Wahner-Roedler. 2009. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clinical Proceedings 84(3):243-247. Stunkel, L., M. Benson, L. McLellan, N. Sinaii, Bedarida G., E. Emanuel, and C. Grady. 2010. Comprehension and informed consent: Assessing the effect of a short consent form. IRB Ethics and Human Research 32(4):1-9. Su, S. C., N. Kanarek, M. G. Fox, A. Guseynova, S. Crow, and S. Piantadosi. 2010. Spatial analyses identify the geographic source of patients at a National Cancer Institute comprehensive cancer center. Clinical Cancer Research 16(3):1065-1072.

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