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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary (2009)
National Cancer Policy Forum (NCPF)

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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary

References

Abrams, J., and M. Mooney. 2008. Memorandum on OHRP regulations on changes in clinical 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 communication 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 October 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).

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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary References Abrams, J., and M. Mooney. 2008. Memorandum on OHRP regulations on changes in clinical 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 communication 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 October 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).

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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary 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 (accessed 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 Medical Association 286(10):1232–1234. DCC (Delaware Cancer Consortium). 2007. Turning commitment into action: Year-three accomplishments. 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 structural, 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 Security 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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