, Volume 12, Issue 3, pp 438-444
Date: 10 Feb 2010

Incrementally Applied Multifaceted Therapeutic Bundles in Neuroprotection Clinical Trials…Time for Change

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Resolution of complex clinical diseases is an extraordinarily difficult challenge. Using neurocritical care and stroke as one example, and the focus of this commentary, we know that efforts to discover effective neuroprotective therapies have met with only limited success. Over 475 completed clinical trials are listed on the Internet Stroke Trials Registry [1] with few reports of demonstrable efficacy in the acute context. Indeed, Donnan [2] in the 2007 Feinberg stroke lecture of the American Heart Association suggests:

We have reached a stage at which research in this area should stop altogether or radical new approaches adopted.

However, these many negative studies belie the supportive basic laboratory studies that justified the enormous time and expense for such disappointing translational clinical trials. Most of these trials evaluated therapies meant to attenuate single pathways in the pathogenesis of brain damage. Examples of this approach with a partial listing of therapeutic tria