Clinical Trials, Devices, Unproven Treatments, and Clinical Equipoise

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 …