Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
Citation：
WU Hongtao,ZHOU Dong,HE Li. Importance of Non-Randomized Controlled Trials. Chinese Journal of Evidence-Based Medicine, 2004, 04(8): 570-572. doi:
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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［8］Temple R, Ellenberg SS. Placebo-controlled trials and activecontrol trials in the evaluation of new treatment. Part 1: Ethical and Scientific Issues[J]. Ann lntern Med, 2000; 133(9):455 - 463.
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［9］PRISMS ( Prevention of R elapses and Disability by Interferonbeta-la Subcataneously in MS ) Study Group. PRISMS-4:Long-term efficacy of interferon-beta-1 a in relapsing MS [J].Neurology, 2001; 56(3): 1 628-1 636.
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［10］Goodkin DE, Reingold S, Sibley W. Guidelines for clinical trials of new therapeutic agents in MS: reporting extended results from phase 3 clinical trials [J]. Ann Neurol,1999; 46(6): 132 -134.
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- 1. ［1］Byar DP, Simon RM, Friedewald WT. Randomized clinical trials: perspectives on some recent ideas [J]. N Engl J Med,1976; 295(5): 74-80.
- 2. ［2］Wang JY. Editor-in-chief. Evidence-based medicine and its clinical practice [ M ]. Shanghai: Science and Technology Publishing House. 2002. 279.
- 3. 王吉耀主编.循证医学与临床实践[M],上海:科学出版社.2002.279.
- 4. ［3］Lublin FD, Reingold SC. Placebo-controlled clinical trials in multiple sclerosis: ethical considerations. National Multiple Sclerosis Society (USA) Task Force on Placebo-Controlled Clinical Trials m MS [J]. Ann Neurol, 2001 ;49(5): 677 -681.
- 5. ［4］Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials [J]. Am J Med, 1982;72(3): 233 - 240.
- 6. ［5］Pocock SJ, Elbourne DR. Randomized trials or observational tribulations [J ] ? N Engl J Med, 2000; 342 ( 25 ): 1 907 -1909.
- 7. ［6］Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C. Choosing between randomized and non-randomised studies : a systematic review [ J ]. Health Technol Assess, 1998;2(13): i-iv,1 -124.
- 8. ［7］Concato J, Shah N, Horwitz RI. Randomized, controlled trials , observational studies, and the hierarchy of research designs [J]. N Engl J Med, 2000; 342(25): 1 887-1 892.
- 9. ［8］Temple R, Ellenberg SS. Placebo-controlled trials and activecontrol trials in the evaluation of new treatment. Part 1: Ethical and Scientific Issues[J]. Ann lntern Med, 2000; 133(9):455 - 463.
- 10. ［9］PRISMS ( Prevention of R elapses and Disability by Interferonbeta-la Subcataneously in MS ) Study Group. PRISMS-4:Long-term efficacy of interferon-beta-1 a in relapsing MS [J].Neurology, 2001; 56(3): 1 628-1 636.
- 11. ［10］Goodkin DE, Reingold S, Sibley W. Guidelines for clinical trials of new therapeutic agents in MS: reporting extended results from phase 3 clinical trials [J]. Ann Neurol,1999; 46(6): 132 -134.
