Data From Controversial Landmark Stroke Therapy Trial Made Publicly Available, And Critics Comment

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Main Category: Clinical Trials / Drug Trials
Also Included In: Stroke
Article Date: 19 May 2008 - 17:00 PDT

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In December 1995, National Institute for Neurological Disorders (NINDS) rt-PA Stroke Trial was published, examining the effects of  the clot-busting drug recombinant tissue plasminogen activator (rt-PA) in patients who had experienced acute stroke. Based on the results of the trial, the FDA approved the use of rt-PA for the treatment of acute ischemic stroke and, subequently, the American Heart Association and the American Academy of Neurology endorsed rt-PA for select patients who had experienced stroke.

Its results had profound implications for the management of stroke in patients, but many experts considered the study highly controversial. Namely, questions were raised about the study's design, results, and ramifications. There is also some skepticism concerning whether the trial results could ever be replicated in a community hospital setting. Finally, it has been noted that there could be an unacceptably high risk of harm for patients using rt-PA.

In an effort to clarify these issues, some of these skeptical experts made multiple requests for access to the NINDS rt-PA trial data. Access was initially denied, even after petitions were made to the Food and Drug Administration under the Freedom of Information Act. Finally, there was an eight year lag before the data were made available for purchase on a CD-ROM in October 2003. The efforts of Dr Robert Dachs (Department of Emergency Medicine, Saint Clare's and Ellis Hospitals, Schenectady, New York, USA) were documented and published on May 19, 2008 in the open-access journal PLoS Medicine. In their article, they summarize the steps taken to access the information, and provide access to the entire database to researchers who would like to analyze the data for independent research queries.

According to Dr. Dachs and his colleagues, the authors of the study have indeed reacted to the questions posed. "The NINDS authors have attempted to address many of these concerns, and supporters have defended and encouraged the increased use of rt-PA in patients with acute stroke." After purchasing the trial dataset, they made several observations about its ease of use -- namely, that gaining access to the information on the CD-ROM was convoluted and difficult. Notably, they pointed out that some of the crucial trial data are missing from the set.

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org.

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org.

A user's guide to the NINDS rt-PA Stroke Trial database.
Dachs RJ, Burton JH, Joslin J
PLoS Med 5(5): e113.
doi:10.1371/journal.pmed.0050113
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Written by Anna Sophia McKenney
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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