Abstract
Most of the advances in treatment and prevention of breast cancer have come from information gained through clinical trials. Fundamental concepts that are now taken for granted, for example, the equivalence of lumpectomy and mastectomy in early-stage breast cancer and the efficacy of endocrine therapy in estrogen receptor positive breast cancer, were not accepted until verified by clinical trials. Clinical trials can take various forms, whether the primary endpoint is assessing safety of a new drug, feasibility of a new technique, or head-to-head comparison of a promising treatment to a previously established standard with improvement in survival as the primary endpoint. An overview of the origins, development, and current embodiment of the major clinical trial groups which focus on breast cancer is provided.
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References
Understanding Clinical Trials. 2009. http://www.clinicaltrials.gov/ct2/info/understand. Accessed 28 Aug 2009.
Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288:321–33.
Clinical Trials. 2009. http://clinicaltrials.gov/info/resources.Accessed 28 Aug 2009.
National Cancer Institute Cancer Therapy Evaluation Program. http://ctep.cancer.gov/ Accessed Aug 28, 2009.
National Cancer Institute Cancer Therapy Evaluation Program Investigator Resources. 2009. http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm. Accessed 28 Aug 2009.
National Cancer Institute Cancer Therapy Evaluation Program Protocol Development. 2009. http://ctep.cancer.gov/protocolDevelopment/. Accessed 28 Aug 2009.
Gebski VJ, Keech AC. Statistical methods in clinical trials. Med J Australia. 2003;178:182–4.
Martin G. Munchausen’s statistical grid, which makes all trials significant. Lancet. 1984;ii:1457.
National Cancer Institute The Central Institutional Review Board. http://www.ncicirb.org. Accessed 28 Aug 2009.
FDA U.S. Food and Drug Administration, CF Code of Federal Regulations Title 21, Sec. 56.107 IRB membership. 2009. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=56.107. Accessed 28 Aug 2009.
NIH Policy for Data and Safety Monitoring. 2009. http://grants1.nih.gov/grants/guide/notice-files/not98-084.html. Accessed 28 Aug 2009.
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ann Intern Med. 2004;141:477–8.
Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration looking back and moving ahead. JAMA. 2007;298:93–4.
International Committee of Medical Journals Editors. 2009. http://www.icmje.org/faq.html. Accessed 28 Aug 2009.
National Cancer Institute Cancer Therapy Evaluation Program. 2009. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed 28 Aug 2009.
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Smith, B.L. (2010). Clinical Trial Overview and Enrollment. In: Dirbas, F., Scott-Conner, C. (eds) Breast Surgical Techniques and Interdisciplinary Management. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-6076-4_28
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DOI: https://doi.org/10.1007/978-1-4419-6076-4_28
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