Recommendations and Practices to Optimize Stroke Therapy

Abstract

On June 20 and 21, 2012, a National Institute of Neurological Disorders and Stroke-sponsored workshop on “Optimizing the Predictive Value of Preclinical Research” was held in Washington, DC.1 The primary objective of the workshop was to review deficiencies in preclinical and translational research and provide recommendations or guidelines to improve the rigor of preclinical research. The following is based on open discussions held at the meeting and panel recommendations for the application of basic principles of experimental design and reporting transparency that are currently standard of practice for stroke clinical trials. This article, which includes author interpretations of discussions, emphasizes the need for good laboratory practices, transparent scientific reporting, and the use of translational research models with clinically relevant end points to develop new strategies to treat stroke. There is a critical medical need for new therapeutic strategies to treat acute ischemic stroke and hemorrhagic stroke to reduce mortality and improve the quality of life for stroke victims. Current US statistics indicate that stroke is the fourth leading cause of death and the leading cause of adult disability in the United States, with upward of 795 000 victims annually who suffer a new or recurrent stroke, despite improved diet, and control of diabetes mellitus, hypertension, and hypercholesterolemia. Currently, the only Food and Drug Administration-approved treatment for stroke is the thrombolytic, tissue plasminogen activator (tPA) if administered within 3 hours of a stroke. Recently, the therapeutic window for tPA has been increased and shown to be beneficial if patients are treated within 4.5 hours of an ischemic stroke.2–4 However, the Food and Drug Administration (FDA) has not yet approved the extension of the time window >3 hours. Although thrombolysis is now widely accepted as a standard of care for acute ischemic stroke, only a minority (6%) of …