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Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Page 98
Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Page 99
Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Page 100
Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Page 101
Suggested Citation:"References." Institute of Medicine. 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12535.
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Page 102

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References Abrams, J., and M. Mooney. 2008. Memorandum on OHRP regulations on changes in clini- cal trial informed consent documents and continued enrollment of new participants. Bethesda, MD, March 20, 2008. ACS (American Cancer Society). 2008. Cancer Facts & Figures 2008. Atlanta, GA: American Cancer Society. Agres, T. 2005. Clinical trials trickling away. Drug Discovery and Development, July 5, 2005. Albrecht, T. L., S. S. Eggly, M. E. J. Gleason, F. W. K. Harper, T. S. Foster, A. M. Peterson, H. Orom, L. A. Penner, and J. C. Ruckdeschel. 2008. The influence of clinical commu- nication on patients’ decision making about clinical trials. Journal of Clinical Oncology 26(16):2666–2673. Butler, P. A. 2000. ERISA and state health care access initiatives: Opportunities and obstacles. New York: The Commonwealth Fund. Chernew, M., D. M. Cutler, and P. S. Keenan. 2005. Increasing health insurance costs and the decline in insurance coverage. Health Services Research 40(4):1021–1039. Chung, C. H., S. Wong, K. K. Ang, E. H. Hammond, A. P. Dicker, P. M. Harari, and Q.-T. Le. 2007. Strategic plans to promote head and neck cancer translational research within Radiation Therapy Oncology Group: A report from the Translational Research Program. International Journal of Radiation Oncology*Biology*Physics 62(2 Suppl):S67–S78. Clinicaltrials.gov. 2008. Cetuximab and/or bevacizumab combined with combination chemotherapy in treating patients with metastatic colorectal cancer. http://clinicaltrials.gov/ct2/show/ NCT00265850?term=CALGB%2FSWOG+C80405&rank=1 (accessed October 6, 2008). CMS (Centers for Medicare and Medicaid Services). 2008a. NCD for routine costs in clinical trials. http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=310.1&ncd_version=2& basket=ncd%3A310%2E1%3A2%3ARoutine+Costs+in+Clinical+Trials (accessed Octo- ber 6, 2008). CMS. 2008b. New HCPCS modifiers when billing for patient care in clinical research studies. http://www.cms.hhs.gov/transmittals/downloads/R1418CP.pdf (accessed October 17, 2008). 97

98 MULTI-CENTER PHASE III CLINICAL TRIALS Comis, R. L., J. D. Miller, C. R. Aldige, L. Kregs, and E. Stoval. 2003. Public attitudes toward participation in cancer clinical trials. Journal of Clinical Oncology 21(5):830–835. Corn, B., I. Wexler, M. Suntharalingam, M. Inbar, W. Curran, and R. T. O. Group. 2008. Globalization of the Radiation Therapy Oncology Group: Implementation of a model for service expansion and public health improvement. Journal of Clinical Oncology 26(7):1160–1166. Covey, S. R. 1989. The seven habits of highly effective people: Powerful lessons in personal change. New York: Free Press. Cox, K., and J. McGarry. 2003. Why patients don’t take part in cancer clinical trials: An overview of the literature. European Journal of Cancer Care 12:114–122. CTEP (Cancer Therapy and Evaluation Program). 1996. Clinical Trials Cooperative Group Program guidelines. http://ctep.cancer.gov/resources/clinical/guidelines1-3.html (ac- cessed October 6, 2008). CTEP. 2008. Clinical Trials Cooperative Group Program. http://ctep.cancer.gov/resources/ coop2.html (accessed September 30, 2008). Davidoff, F., C. D. DeAngelis, J. M. Drazen, J. Hoey, L. Hojgaard, R. Horton, S. Kotzin, M. G. Nicholls, M. Nylenna, A. J. P. M. Overbeke, H. C. Sox, M. B. V. D. Weyden, and M. S. Wilkes. 2001. Sponsorship, authorship, and accountability. Journal of the American Medi- cal Association 286(10):1232–1234. DCC (Delaware Cancer Consortium). 2007. Turning commitment into action: Year-three ac- complishments. http://www.delawarecancerconsortium.org/adx/aspx/adxGetMedia .aspx?DocID=412,466,9,5,1,Documents&MediaID=1129&Filename=DCC_Year3 _Progress_Report.pdf (accessed October 17, 2008). Dignam, J. J. 2004. The role of cancer cooperative groups within the spectrum of cancer care. Cancer Control 11(1):55–63. Dilts, D. M., and A. B. Sandler. 2006. Invisible barriers to clinical trials: The impact of struc- tural, infrastructural, and procedural barriers to opening oncology clinical trials. Journal of Clinical Oncology 24(28):4545–4552. Dilts, D. M., A. B. Sandler, M. Baker, S. K. Cheung, S. L. George, K. S. Karas, S. McGuire, G. S. Menon, J. Reusch, D. Sawyer, M. Scoggins, A. Wu, K. Zhou, and R. L. Schilsky. 2006. Processes to activate Phase III clinical trials in a cooperative oncology group: The case of Cancer and Leukemia Group B. Journal of Clinical Oncology 24(28):4553–4557. Dilts, D. M., A. B. Sandler, S. Cheng, J. Crites, L. Ferranti, A. Wu, R. Gray, J. MacDonald, D. Marinucci, and R. Comis. 2008. Development of clinical trials in a cooperative group setting: The Eastern Cooperative Oncology Group. Clinical Cancer Research 14:3427– 3433. DiMasi, J., and H. Grabowsky. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479. DiMasi, J., R. Hansen, and H. Grabowsky. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151–185. Dodd, L. E., E. L. Korn, B. Freidlin, C. C. Jaffe, L. V. Rubinstein, J. Dancey, and M. M. Mooney. 2008. Blinded independent central review of progression-free survival in phase III clinical trials: Important design element or unnecessary expense? Journal of Clinical Oncology 26(22):3791–3796. DOL (Department of Labor). 2008. Health plans and benefits: Employee Retirement Income Se- curity Act—ERISA. http://www.dol.gov/dol/topic/health-plans/erisa.htm (accessed September 30, 2008). Drucker, P. 2007. The effective executive. Oxford: Elsevier Ltd. Eisenstein, E. L., R. Collins, B. S. Crackness, O. Podesta, E. D. Reid, P. Sandercock, Y. Shakhov, M. L. Terrin, M. A. Sellers, R. M. Califf, C. B. Granger, and R. Diaz. 2008. Sensible approaches for reducing clinical trial costs. Clinical Trials 5(1):75–84.

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100 MULTI-CENTER PHASE III CLINICAL TRIALS Llewellyn-Thomas, H. A., M. J. McGreal, E. C. Thiel, S. Fine, and C. Erlichman. 1991. Pa- tients’ willingness to enter clinical trials: Measuring the association with perceived benefit and preference for decision participation. Social Science & Medicine 32(1):35–42. Lustgarten, A. 2005. Drug testing goes offshore. Fortune. http://money.cnn.com/magazines /fortune/fortune_archive/2005/08/08/8267653/index.htm (accessed October 6, 2008). Mattel, C., Y. Li, L. Beckett, H. Chew, S. Christensen, A. Davies, K. S. Lam, D. Lau, F. Meyers, R. O’Donnell, C. Richman, S. A. Scudder, M. Tanaka, J. Tuscano, J. Welborn, T. Wun, D. R. Gandara, and P. Lara. 2004. An evaluation of barriers to accrual in the era of leg- islation requiring insurance coverage of cancer clinical trial costs in California. Cancer Journal 10(5):294–300. Mauer, A. M., E. S. Rich, and R. L. Schilsky. 2007. The role of cooperative groups in cancer clinical trials. Cancer Treatment and Research 132:111–129. McCaskill-Stevens, W., H. Pinto, A. C. Marcus, R. Comis, R. Morgan, K. Plomer, and S. Schoentgen. 1999. Recruiting minority cancer patients into cancer clinical trials: A pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. Journal of Clinical Oncology 17(3):1029–1039. McNeil, C. 2005. Central IRBs: Why are some institutions reluctant to sign on? Journal of the National Cancer Institute 97(13):953–955. Mills, E. J., D. Seely, B. Rachlis, L. Griffith, P. Wu, K. Wilson, P. Ellis, and J. R. Wright. 2006. Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient-reported factors. Lancet Oncology 7(2):141–148. Moses, H., III, E. Dorsey, D. Matheson, and S. Thier. 2005. Financial anatomy of biomedical research. Journal of the American Medical Association 294(11):1333–1342. NCI (National Cancer Institute). 1997. Report of the National Cancer Institute Clinical Trials Program Review Group. http://deainfo.nci.nih.gov/ADVISORY/bsa/bsa_program/ bsactprgmin.htm#8a (accessed October 6, 2008). NCI. 2000. NCI-Cooperative Group-industry relationship guidelines. http://ctep.cancer.gov/ industry/industry.html (accessed October 6, 2008). NCI. 2003. Community Clinical Oncology Program: Questions and answers. http://www.cancer .gov/cancertopics/factsheet/NCI/CCOP (accessed November 4, 2008). NCI. 2008a. Clinical trials covered under the Medicare Anti-Cancer Drugs Coverage Decision. http://www.cancer.gov/clinicaltrials/developments/NCD179N (accessed October 6, 2008). NCI. 2008b. NCI budget snapshot. http://www.cancer.gov/aboutnci/servingpeople/Snapshot (accessed October 6, 2008). NCSL (National Conference of State Legislatures). 2008. Clinical trials: What are states do- ing? http://www.ncsl.org/programs/health/clinicaltrials.htm (accessed September 30, 2008). Paez, J. G., A. Janne, J. C. Lee, S. Tracy, H. Greulich, S. Gabriel, P. Herman, F. J. Kaye, N. Lindeman, T. J. Boggon, K. Naoki, H. Sasaki, Y. Fujii, M. J. Eck, W. R. Sellers, B. E. Johnson, and M. Meyerson. 2004. EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304(5676):1497–1500. Parexel International Corporation. 2008. Parexel’s Bio/Pharma R&D statistical sourcebook 2008/2009. Needham, MA: Cambridge Healthtech Institute. Ramsey, S. D., and L. G. Kessler. 2002. Does economics matter when treating advanced non- small lung cancer? The Oncologist 7(3):179–180. Schmidt, C. 2007. Cooperative groups say NCI trials funding inadequate; some turn to industry. Journal of the National Cancer Institute 99(11):830–831, 837.

REFERENCES 101 Schulman, K. A., D. M. Seils, J. W. Timbie, J. Sugarman, L. A. Dame, K. P. Weinfurt, D. B. Mark, and R. M. Califf. 2002. A national survey of provisions in clinical-trial agree- ments between medical schools and industry sponsors. New England Journal of Medicine 347(17):1335–1341. Sensible guidelines for the conduct of clinical trials. 2007. Washington, DC. Sheils, J., P. Hogan, and N. Manolov. 1998. Exploring the determinants of employer health insur- ance coverage (report to the AFL-CIO). Washington, DC: The Lewin Group. Shuchman, M. 2007. Commercializing clinical trials—risks and benefits of the CRO boom. New England Journal of Medicine 357(14):1365–1368. Somia, N., and I. M. Verma. 2000. Gene therapy: Trials and tribulations. Nature Reviews Genetics 1(2):91–99. Weinfurt, K. P., D. M. Seils, J. P. Tzeng, L. Lin, K. A. Schulman, and R. M. Califf. 2008. Consis- tency of financial interest disclosures in the biomedical literature: The case of coronary stents. PLoS One 3(5):e2128. Wirth, T., and S. Yla-Herttuala. 2006. Gene technology based therapies in the brain. Advances and Technical Standards in Neurosurgery 31:3–32. Wright, J. R., T. J. Whelan, S. Schiff, S. Dubois, D. Crooks, P. T. Haines, D. DeRosa, R. S. Roberts, A. Gafni, K. Pritchard, and M. N. Levine. 2004. Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision. Journal of Clinical Oncology 22(21):4312–4318. Yun, C.-H., K. E. Mengwasser, A. V. Toms, M. S. Woo, H. Greulich, K.-K. Wong, M. Meyerson, and M. J. Eck. 2008. The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. PNAS 105(6):2070–2075.

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The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness.

To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.

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