The use of a global statistical approach for the design and data analysis of clinical trials with multiple primary outcomes

Experimental Stroke

Volumn , Issue , 2008, Pages 100-108

  Huang, Peng ^a,b   Woolson, Robert F ^b   Granholm, Ann Charlotte ^c  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70449989055     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.2174/978160805001710901010100     Document Type: Chapter

References (27)

1. Adams HP, Woolson RF, Clarke W, et al. Design of Org 10172 in acute ischemic stroke treatment (TOAST): implications for other trials of treatments of persons with acute ischemic stroke. Controlled Clinical Trials 1997; 18: 358-77.
2. Publications Committee for the Trial of Org 10172 in Acute Stroke Treatment (TOAST) Investigators. Results of a randomized, placebo-controlled trial of the low molecular weight heparinoid, Org 10172, in improving outcome after acute ischemic stroke. J Am Med Assoc 1998; 279: 1265-72.
3. Tilley BC, Alarcon GS, Heyse SP, et al. Minocycline in rheumatoid arthritis: A 48-week double-blind, placebo controlled trial. Ann Intern Med 1995; 122: 81-9.
4. O'Brien P, Geller N. Interpreting tests for efficacy in clinical trials with multiple endpoints. Control Clin Trials 1997; 18: 222-7.
5. O'Brien P. Procedures for comparing samples with multiple endpoints. Biometrics 1984; 40:1079-87.
6. Tang D, Gnecco C, Geller NL. Design of group sequential clinical trials with multiple endpoints. J Am Stat Assoc 1989; 84(407): 776-9.
7. Tilley BC, Marler J, Geller NL, et al. Use of a Global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke T-PA stroke trial. Stroke 1996; 27(11): 2136-42.
8. Lefkopoulou M, Moore D, Ryan L. The analysis of multiple correlated binary outcomes: application to rodent teratology experiments. J Am Stat Assoc 1989; 84(407):810-5.
9. Acion L, Peterson JJ, Temple S, Arndt S. Probabilistic index: an intuitive non-parametric approach to measuring the size of treatment effects. Stat Med 2006, 25: 591-602.
10. Wolfe, DA, Hogg, RV. On constructing statistics and reporting data. Am Stat 1971; 25: 27-30.
11. Huang P, Woolson RF, O'Brien PC. A rank-based sample size method for multiple outcomes in clinical trials. Stat Med 2008; 27: 3084-104.
12. Huang P, Tilley BC, Woolson RF, Lipsitz SR. Adjusting O'Brien's test to control type I error for the generalized nonparametric Behrens-Fisher problem. Biometrics 2005; 61: 532-9.
13. The NINDS NET-PD Investigators. A randomized, double blinded, futility clinical trial of creatine and minocycline in early Parkinson's disease. Neurology 2006; 66: 664-71.
14. The NINDS NET-PD Investigators. A randomized clinical trial of Coenzyme Q10 and GPI-1485 in early Parkinson's disease. Neurology 2007; 68: 20-8.
15. Olanow CW, Kieburtz K, Stern M, et al. Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease. Arch Neurol 2004; 61: 1563-8.
16. The NINDS NET-PD Investigators. A randomized, double blinded, futility clinical trial of creatine and minocycline in early Parkinson's disease. Neurology 2006; 66: 664-71.
17. Parkinson Study Group. Impact of deprenyl and tocopherol treatment on Parkinson's disease in DATATOP patients requiring levodopa. Ann Neurol 1996; 39: 37-45.
18. Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004; 61: 1044-53.
19. Kieburtz KK, McDermott M, Como P, et al. The effect of deprenyl and tocopherol on cognitive performance in early untreated Parkinson's disease. Neurology 1994; 44: 1756-9.
20. Shults CW, Oakes D, Karl KM, et al. Effects of Coenzyme Q10 in Early PD: Evidence of Slowing of the Functional Decline. Arch Neurol 2002; 59: 1541-50.
21. Parkinson Study Group. A multicenter randomized controlled trial of remacemide hydrochloride as monotherapy for PD. Neurology 2000; 54(8): 1583-8.
22. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue Plasminogen Activator for Acute Ischemic Stroke. N Engl J Med 1995; 333: 1581-7.
23. Tilley BC, Marler J, Geller NL, et al. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA stroke trial. Stroke 1996; 27: 2136-42.
24. Kaufman KD, Olsen EA, Whiting D, Savin R, De Villez R, Bergfeld W. Finasteride in the treatment of men with androgentic alopecia. J Am Acad Dermatol 1998; 39: 578-89.
25. Li DK, Zhao GJ, Paty DW. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology 2001; 56(11): 1505-13.
26. Shames RS, Heilbron DC, Janson SL, Kishiyama JL, Au, DS, Adelman DC. Clinical differences among women with and without self-reported perimenstrual asthma. Ann Aller Asth Immunol 1998; 81: 65-72.
27. Tilley BC, Pillemer SR, Heyse SP, et al. Global test for comparing multiple outcomes in rheumatoid arthritis trials, Arthritis Rheum 2000; 42(9): 1879-88.