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The Phase II Futility Clinical Trial Design

Published online by Cambridge University Press:  20 September 2006

Bernard Ravina  and
Yuko Palesch
Bernard Ravina
Affiliation:
University of Rochester Medical Center, Rochester, NY; Email: [email protected]
Yuko Palesch
Affiliation:
Medical University of South Carolina, Charleston, SC
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Abstract

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Keywords

Futilityclinical trialsPhase IIhistorical control
Type
Review Article
Information
Progress in Neurotherapeutics and Neuropsychopharmacology , Volume 2 , Issue 1 , March 2007 , pp. 27 - 38
Copyright
© 2007 Cambridge University Press

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References

Clark, W.M. et al. (1999). Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. Journal of the American Medical Association, 282, 2019–2026.Google Scholar
Elm, J.J., Goetz, C.G., Ravina, B., Shannon, K., Wooten, G.F., Tanner, C., et al. (2005). A responsive outcome for Parkinson's disease neuroprotection futility studies. Annals of Neurology, 57 (2), 197–203.Google Scholar
Food and Drug Administration (1997). In Federal Register, Vol 24. (ed. HHS) 66113–66118.
Gehan, E.A. (1986). Update on planning of phase II clinical trials. Drugs under Experimental and Clinical Research, 12, 43–50.Google Scholar
Green, S., Benedetti, J., & Crowley, J. (1997). Clinical Trials in Oncology. London: Chapman & Hall.
Hacke, W. et al. (1998). Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet, 352, 1245–1251.Google Scholar
Herson, J. (1979). Predictive probability early termination plans for phase II clinical trials. Biometrics, 35, 775–783.Google Scholar
Herson, J., & Carter, S.K. (1986). Calibrated phase II clinical trials in oncology. Statistics in Medicine, 5, 441–447.Google Scholar
Kidwell, C.S., Liebeskind, D.S., Starkman, S., & Saver, J.L. (2001). Trends in acute ischemic stroke trials through the 20th century. Stroke, 32, 1349–1359.Google Scholar
Lee, J.J., & Feng, L. (2005). Randomized phase II designs in cancer clinical trials: current status and future directions. Journal of Clinical Oncology, 23, 4450–4457.Google Scholar
Palesch, Y.Y., Tilley, B.C., Sackett, D.L., Johnston, K.C., & Woolson, R. (2005). Applying a phase II futility study design to therapeutic stroke trials. Stroke, 36, 2410–2414.Google Scholar
Piantadosi, S. (1997). Clinical Trials: A Methodological Perspective. New York: John Wiley & Sons Inc.
Pocock, S.J. (1976). The combination of randomized and historical controls in clinical trials. Journal of Chronic Diseases, 29, 175–188.Google Scholar
Ravina, B. (2006). NINDS Net PD Investigators; A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease. Neurology, Mar 14; 66 (5): 664–671. Epub 2006 Feb 15.Google Scholar
Ravina, B.M., et al. (2003). Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology, 60, 1234–1240.Google Scholar
Ravina, B., Janis, S., Keleti, J., & Marler, J.M. (2004). Funding evidence: the National Institute of Neurological Disorders and Stroke Clinical Trials Program. NeuroRx, 1, 317–322.Google Scholar
Shults, C.W. et al. (2002). Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Archives of Neurology, 59, 1541–1550.Google Scholar
The Interventional Management of Stroke Study (2004). Combined intravenous and intra-arterial recanalization for acute ischemic stroke. Stroke, 35, 904–911.
The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group (1995). Tissue plasminogen activator for acute ischemic stroke. New England Journal of Medicine, 333, 1581–1587.
The Parkinson Study Group (1989). Effect of deprenyl on the progression of disability in early Parkinson's disease. New England Journal of Medicine, 321, 1364–1371.
The Publications Committee (TOAST) Investigators (1998). Low molecular weight heparinoid, ORG 10172 (danaparoid), and outcome after acute ischemic stroke: a randomized controlled trial. The Publications Committee for the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators. Journal of American Medical Association, 279, 1265–1272.
The RANTTAS Investigators (1996). A randomized trial of tirilazad mesylate in patients with acute stroke (RANTTAS). Stroke, 27, 1453–1458.
Tilley, B.C., Palesch, Y.Y., Kieburtz, K., Ravina, B., et al. Optimizing the ongoing search for new treatments for Parkinson disease: Using futility designs. Neurology, 2006; 66 (5): 628–633.Google Scholar