New pathways for evaluating potential acute stroke therapies

International Journal of Stroke : Official Journal of the International Stroke Society
Marc FisherSteven Warach

Abstract

Pharmacological therapy for acute ischemic stroke remains limited to one successful, approved treatment: tissue plasminogen activator within 3 h of stroke onset. Many neuroprotective drugs and a few other thrombolytics were evaluated in clinical trials, but none demonstrated unequivocal success and were approved by regulatory agencies. The development paradigm for such therapies needs to provide convincing evidence of efficacy and safety to obtain approval by the Food and Drug Administration (FDA). The FDA modernization act of 1997 stated that such evidence could be derived from one large phase III trial with a clinical endpoint and supportive evidence. Drugs being developed for acute ischemic stroke can potentially be approved under this act by coupling a major phase III trial with supportive evidence provided by a phase IIB trial demonstrating an effect on a relevant biomarker such as magnetic resonance imaging or computed tomography assessment of ischemic lesion growth. Statistical approaches have been developed to optimize the design of such an imaging-based phase IIB study, for example approaches that modify randomization probabilities to assign larger proportions of patients to the 'winning' strategy (i.e. 'pick the winne...Continue Reading

References

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Citations

Sep 3, 2011·Stroke; a Journal of Cerebral Circulation·Ken Cheung, Petra Kaufmann
Feb 18, 2010·Biomarkers in Medicine·Matthew B Maas, Karen L Furie
Nov 28, 2013·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Wendy R GalpernH A Jinnah
Mar 3, 2009·Expert Opinion on Emerging Drugs·Kenneth M Sicard, Marc Fisher
Jun 19, 2008·AACN Advanced Critical Care·Anne W Wojner Alexandrov
Sep 27, 2015·Contemporary Clinical Trials·Amber SalterInmaculada B Aban
Apr 19, 2013·Neurological Research·Marc Fisher
Dec 18, 2010·Stroke; a Journal of Cerebral Circulation·Marc Fisher

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