RANDOMIZED CONSENT DESIGNS FOR CLINICAL-TRIALS - AN UPDATE

被引:222
作者
ZELEN, M
机构
[1] Harvard School of Public Health and Dana-Farber Cancer Institute, Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, 02115
关键词
D O I
10.1002/sim.4780090611
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Randomized consent designs were introduced to make it easier for physicians to enter patients in randomized clinical trials. Physician reluctance to participate in randomized clinical trials is often a reflection that the physician‐patient relationship could be compromised if the physician makes known to the patient his/her inability to select a preferred therapy. Clinical trials having a no‐treatment control or placebo amplify this concern. This paper reviews the main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis, and presents some recent experiences. Copyright © 1990 John Wiley & Sons, Ltd.
引用
收藏
页码:645 / 656
页数:12
相关论文
共 17 条
[1]  
Zelen M., Statistical options in clinical trials, Seminars in Oncology, 4, pp. 441-446, (1977)
[2]  
Zelen M., A new design for randomized clinical trials, New England Journal of Medicine, 300, pp. 1242-1245, (1979)
[3]  
Zelen M., Alternatives to classic randomized trials, Surgical Clinics of North America, 61, pp. 1425-1432, (1981)
[4]  
Zelen M., Strategy and alternate designs in cancer clinical trials, Cancer Treatment Reports, 66, pp. 1095-1100, (1982)
[5]  
Anbar D., The relative efficiency of Zelen's prerandomization design for clinical trials, Biometrics, 39, pp. 711-718, (1983)
[6]  
McHugh R., Validity and treatment dilution in Zelen's single‐consent design, Statistics in Medicine, 3, pp. 215-218, (1984)
[7]  
Matts J., McHugh R., Randomization and efficiency in Zelen's single consent design, Biometrics, 43, pp. 885-894, (1987)
[8]  
Zelen M., Commentary on Randomization and optimal design, Journal of Chronic Diseases, 36, pp. 613-614, (1983)
[9]  
Zelen M., Response, Journal of Chronic Diseases, 39, pp. 247-249, (1986)
[10]  
Curran W.J., Reasonableness and randomization in clinical trials: fundamental law and governmental regulation, New England Journal of Medicine, 300, pp. 1273-1275, (1979)