Practical Guidelines for Multiplicity Adjustment in Clinical Trials

Controlled Clinical Trials - Tập 21 Số 6 - Trang 527-539 - 2000
Michael A. Proschan1, Myron A. Waclawiw2
1Office of Biostatistics Research, National Heart, Lung and Blood Institute, Bethesda, MD 20892-7938, USA. [email protected]
2Office of Biostatistics Research, National Heart, Lung and Blood Institute, Bethesda, MD USA

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Tài liệu tham khảo

Hochberg, 1987

Rothman, 1990, No adjustments are needed for multiple comparisons, Epidemiology, 1, 43, 10.1097/00001648-199001000-00010

Duncan, 1955, Multiple range and multiple F tests, Biometrics, 11, 1, 10.2307/3001478

O'Brien, 1983, The appropriateness of analysis of variance and multiple comparison procedures, Biometrics, 39, 787, 10.2307/2531110

Hughes, 1998, Multiplicity in clinical trials

ISIS-2 Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988; 349–360.

Capizzi, 1996, Testing the hypothesis that matters for multiple primary endpoints, Drug Information Journal, 30, 949, 10.1177/009286159603000410

Davis BR, Cutler JA, Gordon DJ, et al. for the ALLHAT Research Group. Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Am J Hypertens 1996;9:342–360.

Proschan, 1995, Multiple comparisons with control in a single experiment versus separate experiments, The American Statistician, 49, 144, 10.2307/2684628

Friedman, 1998, P-value interpretation and Alpha allocation in clinical trials, Ann Epidemiol, 8, 349

Horwitz, 1996, Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation, J Clin Epidemiol, 49, 395, 10.1016/0895-4356(95)00058-5

The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. New Engl J Med 1996;335:217–225.

Buxton, 1999, A randomized study of the prevention of sudden death in patients with coronary artery disease, New Engl J Med, 341, 1882, 10.1056/NEJM199912163412503

Hulley, 1998, for the Heart and Estrogen/progestin Replacement Study (HERS) research group. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women, JAMA, 280, 605, 10.1001/jama.280.7.605

Shih, 1999, Planning and analysis of repeated measures at key time-points in clinical trials sponsored by pharmaceutical companies, Stat Med, 18, 961, 10.1002/(SICI)1097-0258(19990430)18:8<961::AID-SIM83>3.0.CO;2-I

Miller, 1981

Geller N, O'Brien P. Simultaneous Inference. In: Kotz S, Johnson NL, Read CB, eds. Encylopedia of Biostatistics. New York: John Wiley and Sons; 1998.

1995, Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women, JAMA, 273, 199, 10.1001/jama.1995.03520270033028

Proschan, 1999, A multiple comparison procedure for three- and four-armed controlled clinical trials, Stat Med, 18, 787, 10.1002/(SICI)1097-0258(19990415)18:7<787::AID-SIM77>3.0.CO;2-M

Fisher, 1935

Moyé, 2000, Alpha calculus in clinical trials, Stat Med, 19, 767, 10.1002/(SICI)1097-0258(20000330)19:6<767::AID-SIM518>3.0.CO;2-U