[1] 田少雷,邵庆翔.药物临床试验与GCP实用指南[M].北京: 北京大学医学出版社, 2010, (1). [2] The World Medical Association. World Medical Association Declaration of Helsinki [EB/OL] .http://www.wma.net/e/policy/b3.htm. [3] Benjamin Freedman, Charles Weijer, Kathleen CranleyGlass. Placebo orthodoxy in clinical research I: Empirical and methodological myths. The Journal of Law, Medicine & Ethics, 1996; 24:243-251. [4] Ezekiel J. Emanuel, Franklin G. Miller. The Ethics of Placebo-controlled Trials - A Middle Ground, The New England Journal of Medicine, vol. 345, No.22 ,September 20, 2001. [5] Lorraine G. Allan, Shepard Siegel. A Signal Detection Theory Analysis of the Placebo Effect.Evaluation& the Health Professions, vol. 25, no. 4, December 2002: 410-420. [6] Mark J Bolland, P Alan Barber, Robert N Doughty, et al. Vascular events in healthy older women receiving calcium supplementation: Randomized controlled trial. British Medical Journal, January 2008; 336: 262. [7] Jeremy Howick. Questioning the Methodologic Superiority of ‘Placebo’ over ‘Active’ Controlled Trials.TheAmerican Journal of Bioethics 2009.vol. 9(9): 34-48. [8] Robert Temple, Susan S. Ellenberg. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues. Annals of Internal Medicine, 2000; 133: 455-463. [9] 周宏灏,袁洪.药物临床试验 [M],北京:人民卫生出版社,2011, (3). [10] Henry Knowles Beecher. Ethics and clinical research.New England Journal of Medicine 1966; 274: 1354-1360. [11] Brian Vastag. Helsinki Discord? A Controversial Declaration.JAMA, 2000;284(23):2983-2985. [12] US Food and Drug Administration. Guidance for industry: E 10 choice of control group and related issues in clinical trials. May 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073139.pdf. Accessed September 5, 2012. [13] Robert J. Levine. Placebo controls in clinical trials of new therapies for conditions for which there are known effective treatments. In Guess HA, Kleinman A, Kusek JW and Engel, LW (editors) The Science of the Placebo: Toward an Interdisciplinary Research Agenda, BMJ Books, London, 2002. [14] Food and Drug Administration. Guidance for industry: botanical drug products.2004;9-10. http://www.fda.gov/cder/guidance/index.htm [15] Rebecca Kukla. Resituating the Principle of Equipoise: Justice and Access to Care in Non-Ideal Conditions. Kennedy Institute of Ethics Journal, vol 17, no 3, September 2007:171-202. |