Monday, April 22, 2013

Why the United States Needs a Network for Stroke Clinical Trials

One of the authors - Story - is director of the NINDS. Another failure of the existing stroke associations, they should be providing such support.
http://stroke.ahajournals.org/content/44/5/1217.extract.html?etoc

Introduction

Stroke is the fourth leading cause of death in the United States, and it is a major cause of long-term disability and reduced quality of life for hundreds of thousands of Americans. Over the past decades, teams of National Institute of Neurological Disorders and Stroke (NINDS)–funded clinical trialists have consistently made major contributions toward treating stroke acutely, enhancing its prevention and rehabilitation, and thereby improving the health of the country. However, although stroke research has resulted in improved outcomes, the increasing incidence with aging of the population and substantial disability and mortality associated with stroke remain a significant burden for a growing number of stroke patients each year. At the recent NINDS stroke planning meeting, external clinicians and researchers identified that enhancing clinical trial infrastructure is one of the highest priorities for the Institute to address in its effort to advance stroke care in the United States.1

Recognizing the Challenges of Clinical Research

The NINDS typically funds between 20 and 50 phase II and III stroke trials, investing between $30 and $70 million per year. Trials are generally funded in response to investigator-initiated research proposals that are judged to be highly meritorious by a special clinical research peer review committee. Before accepting trial grants for peer review, the NINDS leadership evaluates proposals for their potential to reduce the burden of illness caused by stroke. The trials are performed by large teams self-assembled around single projects that are championed by a principal investigator and a cadre of hard-working co-investigators. However, the execution of trials requires the work of hundreds. Traditionally, necessary personnel and infrastructure are assembled anew for each trial once a grant receives funding. Trial infrastructure is then disassembled once the trial is completed. Protracted negotiations over protocols and trial agreements delay study start-up, increasing costs. In addition to the inherent inefficiency of time and resources involved in duplication of infrastructure for each trial, the current system makes it difficult to continuously improve methods or infrastructure based on lessons learned.

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