References

BRAF targets in melanoma. Biological mechanisms, resistance, and drug discovery. Cancer drug discovery and development. Volume 82. Ed. Ryan J. Sullivan. Springer (2015)


  1. Drucker CB. Ambroise pare and the birth of the gentle art of surgery. Yale J Biol Med. 2008 Dec;81(4):199–202.
  2. Greenstone G. The roots of evidence-based medicine. BCMJ. 2009;51(8):342–4.
  3. Marshall G (Chairman) et al. Streptomycin treatment of pulmonary tuberculosis. Br Med J. 1948 Oct 30;2(4582):769–82.
  4. Yoshioka A. The randomized controlled trial of Streptomycin. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 46–60.
  5. Weindling P. The Nazi medical experiments. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 18–30.
  6. Annas GJ, Grodin MA. The Nuremberg code. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 136–40.
  7. Nuremberg Military Tribunal. The Nuremberg code. JAMA. 1996 Nov 27;276(20):1691.
  8. The Nuremberg Code. Washington, DC: U.S. Government Printing Office. 1949. http://www. hhs.gov/ohrp/archive/nurcode.html.
  9. Jones JH. The Tuskegee Syphilis experiment. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 86–96.
  10. Heller J. Syphilis victims in U.S. study went untreated for 40 years. New York Times. 1972.
  11. National Center for HIV/AIDS VH, STD, and TB Prevention, Centers for Disease Control and Prevention. The Tuskegee Timeline. http://www.cdc.gov/tuskegee/timeline.htm.
  12. The National Research Act. Public Law 93–348. (July 12, 1974). Accessed 8 March 2013.
  13. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. The Belmont Report (1979). [cited 2013 March 8]. http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.html. Accessed 8 March 2013.
  14. Sibbald B. Death but one unintended consequence of gene-therapy trial. CMAJ. 2001 May 29;164(11):1612.
  15. Steinbrook R. The Gelsinger case. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 110–20.
  16. Batshaw ML, Wilson JM, Raper S, Yudkoff M, Robinson MB. Recombinant adenovirus gene transfer in adults with partial ornithine transcarbamylase deficiency (OTCD). Hum Gene Ther. 1999 Sep 20;10(14):2419–37.
  17. Raper SE, Yudkoff M, Chirmule N, Gao GP, Nunes F, Haskal ZJ, et al. A pilot study of in vivo liver-directed gene transfer with an adenoviral vector in partial ornithine transcarbamylase deficiency. Hum Gene Ther. 2002 Jan 1;13(1):163–75.
  18. The Declaration of Helsinki. Seoul, Korea (2008) [cited 2013 March 8]; 6th revision: http://www.wma.net/en/30publications/10policies/b3/index.html . Accessed 8 March 2013.
  19. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects; 1993.
  20. S. Department of Health and Human Services. Title 45 Public Welfare CFR 46. 2009. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html . Accessed 8 March 2013.
  21. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24–31;283(20):2701–11.
  22. Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. 1st edn. New York: Oxford University Press; 2008.
  23. Gillon R. Medical ethics: four principles plus attention to scope. BMJ. 1994;309(6948):184–8.
  24. Rothman KJ. Epidemiology: an introduction. 2nd edn. New York: Oxford University Press; 2012.
  25. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med. 2000 Sep 19;133(6):464–70.
  26. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med. 2000 Sep 19;133(6):455–63.
  27. Joffe S, Truog RD. Equipoise and randomization In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 245–59.
  28. Friedman LM, Furberg CD, DeMets DL. Ethical issues. In Friedman LM, Furberg CD, DeMets DL, editors. Fundamentals of clinical trials. 4th edn. New York: Springer 2010. p. 19–36.
  29. Emanuel EJ, Wendler D, Grady C. An ethical framework of biomedical research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 123–35.
  30. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987 Jul 16;317(3):141–5.
  31. Fried C. Medical experimentation: personal integrity and social policy. New York: Elsevier; 1974.
  32. Schafer A. The ethics of the randomized clinical trial. N Engl J Med. 1982 Sep 16;307(12):719–24.
  33. Keirns CC, Goold SD. Patient-centered care and preference-sensitive decision making. JAMA. 2009 Oct 28;302(16):1805–6.
  34. Miller PB, Weijer C. Rehabilitating equipoise. Kennedy Inst Ethics J. 2003 Jun;13(2):93–118.
  35. Miller FG, Joffe S. Equipoise and the dilemma of randomized clinical trials. N Engl J Med. 2011 Feb 3;364(5):476–80.
  36. Bruzzi P, Del Mastro L, Sormani MP, Bastholt L, Danova M, Focan C, et al. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol. 2005 Aug 1;23(22):5117–25.
  37. Tang PA, Bentzen SM, Chen EX, Siu LL. Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol. 2007 Oct 10;25(29):4562–8.
  38. Johnson KR, Ringland C, Stokes BJ, Anthony DM, Freemantle N, Irs A, et al. Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or nonsmall-cell lung cancer: a meta-analysis. Lancet Oncol. 2006 Sep;7(9):741–6.
  39. Wagner AD, Thomssen C, Haerting J, Unverzagt S. Vascular-endothelial-growth-factor (VEGF) targeting therapies for endocrine refractory or resistant metastatic breast cancer. Cochrane Database Syst Rev. 7:CD008941.
  40. Meropol NJ, Schulman KA. Cost of cancer care: issues and implications. J Clin Oncol. 2007 Jan 10;25(2):180–6.
  41. Gifford F. Community-equipoise and the ethics of randomized clinical trials. Bioethics. 1995 Apr;9(2):127–48.
  42. Miller FG. The ethics of placebo-controlled trials. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 261–72.
  43. Food and Drug Administration. Guidance for Industry; E10 Choice of Control Group and Related Issues in Clinical Trials. Department of Health and Human Services; 2001.
  44. Clark PI, Leaverton PE. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health. 1994;15:19–38.
  45. Emanuel EJ, Miller FG. The ethics of placebo-controlled trials—a middle ground. N Engl J Med. 2001 Sep 20;345(12):915–9.
  46. Gralla RJ, Itri LM, Pisko SE, Squillante AE, Kelsen DP, Braun DW Jr, et al. Antiemetic efficacy of high-dose metoclopramide: randomized trials with placebo and prochlorperazine in patients with chemotherapy-induced nausea and vomiting. N Engl J Med. 1981 Oct 15;305(16):905–9.
  47. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993 Aug 19;329(8):573–6.
  48. Levinsky NG. Nonfinancial conflicts of intereskt in research. N Engl J Med. 2002 Sep 5;347(10):759–61.
  49. Bowen AJ. Models of institutional review board function In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 552–9.
  50. Speers MA. Evaluating the effectiveness of institutional review boards. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 560–8.
  51. Friedman LM, Schron EB. Data and safety monitoring boards. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 569–76.
  52. Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med. 2004 Mar 11;350(11):1143–7.
  53. Fleming TR, DeMets DL. Monitoring of clinical trials: issues and recommendations. Control Clin Trials. 1993 Jun;14(3):183–97.
  54. Canner PL. The Coronary Drug Project. Monitoring of the data for evidence of adverse or beneficial treatment effects. Control Clin Trials. 1983 Dec;4(4):467–83.
  55. Brock DW. Philosophical justifications of informed consent in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 606–12.
  56. Capron AM. Legal and regulatory standards of informed consent in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 613–32.
  57. Agrawal M, Emanue EJ. Phase I oncology research In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2010. p. 356–66.
  58. Doyle C, Crump M, Pintilie M, Oza AM. Does palliative chemotherapy palliate? Evaluation of expectations, outcomes, and costs in women receiving chemotherapy for advanced ovarian cancer. J Clin Oncol. 2001 Mar 1;19(5):1266–74.
  59. Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ. Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol. 2006 Sep 20;24(27):4479–84.
  60. Malmqvist E, Juth N, Lynoe N, Helgesson G. Early stopping of clinical trials: charting the ethical terrain. Kennedy Inst Ethics J. 2011 Mar;21(1):51–78.
  61. Miller FG, Wendler D. Is it ethical to keep interim findings of randomised controlled trials confidential? J Med Ethics. 2008 Mar;34(3):198–201.
  62. Wells RJ, Gartside PS, McHenry CL. Ethical issues arising when interim data in clinical trials is restricted to independent data monitoring committees. IRB. 2000 Jan;22(1):7–11.
  63. Cannistra SA. The ethics of early stopping rules: who is protecting whom? J Clin Oncol. 2004 May 1;22(9):1542–5.
  64. Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460–5.
  65. Ozols RF. Maintenance therapy in advanced ovarian cancer: progression-free survival and clinical benefit. J Clin Oncol. 2003 Jul 1;21(13):2451–3.
  66. Balch CM, Buzaid AC, Soong SJ, Atkins MB, Cascinelli N, Coit DG, et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol. 2001 Aug 15;19(16):3635–48.
  67. Lui P, Cashin R, Machado M, Hemels M, Corey-Lisle PK, Einarson TR. Treatments for metastatic melanoma: synthesis of evidence from randomized trials. Cancer Treat Rev. 2007 Dec;33(8):665–80.
  68. Sullivan RJ, Atkins MB. Cytokine therapy in melanoma. J Cutan Pathol. [Review]. 2010 Apr; 37(Suppl 1):60–7.
  69. Flaherty KT, editor. Phase I study of PLX4032: proof of concept for V600E BRAF mutation as a therapeutic target in human cancer. American Society of Clinical Oncology 2009 Annual Meeting. Chicago: Journal of Clinical Oncology; 2009.
  70. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. Aug 26 2010;363(9):809–19.
  71. Harmon A. New drugs stir debate on rules of clinical trials. New York Times. 2010 Sept 18.
  72. Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745–51.
  73. Chapman PB, Hauschild A, Robert C, Larkin JM, Haanen JB, Ribas A, et al. Updated overall survival (OS) results for BRIM-3, a phase III randomized, open-label, multicenter trial comparing BRAF inhibitor vemurafenib (vem) with dacarbazine (DTIC) in previously untreated patients with BRAFV600E-mutated melanoma. J Clin Oncol. 2012;30(suppl; abstr 8502).
  74. Guidance for Industry: clinical trial endpoints for the approval of cancer drugs and biologics. Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf . Accessed 8 Mar 2013. Food and Drug Administration 2007.
  75. FDA news release: FDA Commissioner announces avastin decision. 2011 [cited 2013 March 8]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280536.htm . Accessed 8 March 2013.
  76. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666–76.
  77. Miles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3239–47.
  78. Robert NJ, Dieras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011 Apr 1;29(10):1252–60.

[contact-form-7 id=»5168″ title=»Контактная форма 1″]

0

Добавить комментарий

Войти с помощью: 

Ваш e-mail не будет опубликован. Обязательные поля помечены *