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(Stroke. 2009;40:e441.)
© 2009 American Heart Association, Inc.

Comments, Opinions, and Reviews

Clinical Trials, Devices, Unproven Treatments, and Clinical Equipoise

Warren W. Wasiewski, MD Karen C. Johnston, MD, MSc

From the Neurobiological Technologies, Inc (W.W.W.), Edgewater, NJ; and the Department of Neurology (K.C.J.), University of Virginia, Charlottesville, Va.

Correspondence to Warren W. Wasiewski, MD, Neurobiological Technologies, Inc, 2000 Powell St, Suite 800, Emeryville, CA 94608. E-mail runnerw3@yahoo.com

Key Words: clinical trials • devices • equipose • stroke treatment

An extract of the first 250 words of the full text is provided, because this article has no abstract.

The importance of unbiased comparative research trials to answer clinical questions that guide best treatment practices is unquestionable. Large multicenter clinical trials are critical for answering important clinical questions that cannot be answered by observational data. These studies depend on adequate recruitment from unbiased samples of patients from the population of interest. Investigators participating in such trials must also have clinical equipoise that the treatment under study may or may not be better than the standard treatments available. If such clinical equipoise does not exist, then recruitment will be biased and potentially delayed. In recent years, stroke clinical trials have struggled to enroll patients to acute trials for a variety of reasons, including narrow eligibility time windows and, most recently, to the growing list of available, although not necessarily safe or efficacious, therapies.

In January 2008, the US Food and Drug Administration cleared the second device for removal of blood clots from the central nervous system vasculature, the Penumbra System.¹ The device was cleared based on demonstration of substantial equivalence to legally marketed predicate devices, in this case, the Merci Retriever models X5 and X6 in bench, in vitro, in vivo, and in clinical testing. The clinical data were presented as a late-breaking abstract at the International Stroke Conference 2008.² The Merci Retriever has been available since it received US Food and Drug Administration clearance in 2004.³ These devices were both studied in a time window of 8 hours from stroke onset. Neither device has demonstrated safety or efficacy in . . . [Full Text of this Article]