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Funding News - NINDS Invites Committee to Review t-PA Study Data

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The NINDS recently invited an independent committee to review and consider the data from the five-year, multi-site “Tissue Plasminogen Activator for Acute Ischemic Stroke” study, published by the NINDS r-TPA Stroke Study Group in The New England Journal of Medicine, December 14, 1995. The study represents the first treatment for acute ischemic stroke, and the therapeutic agent t-PA was approved by the FDA for this usage in June of 1996.

In recent months, public debate about the study findings has resulted in some discussion within the medical community about the appropriate use of this treatment for stroke. In answer to this, the NINDS asked that the committee “address whether there is concern that eligible stroke patients may not benefit from rt-PA given according to the protocol used in the (NINDS) trials, and whether any subgroup imbalances invalidate the trial as claimed by some of the critics.”

The committee is chaired by W. Michael O’Fallon, Ph.D., professor of Biostatistics, former chair at the Department of Health Sciences Research at the Mayo Clinic, in Rochester, Minnesota, and a recent past president of the American Statistical Association. Dr. O’Fallon chose the members of the committee, who represent an international cadre of physician-scientists with expertise in biostatistics, clinical medicine, cerebrovascular disease, neurology, and emergency medicine. None of the committee members has a connection with the previous published study or with the manufacturer of t-PA. (See roster of the committee members below.)

The committee has full access to the study data, will re-analyze the study, and hopes to report its findings by early spring. The NINDS looks forward to the group’s findings and the presentation of the data analysis at professional meetings and in the scientific literature.

Committee Roster

W. Michael O'Fallon, Ph.D., Chair
Professor of Biostatistics
Mayo Clinic

Timothy J. Ingall, M.B. B.S., Ph.D.
Associate Professor of Neurology
Cerebrovascular Diseases Center
Mayo Clinic Scottsdale

Professor Thomas A. Louis, Ph.D.
Department of Biostatistics
Johns Hopkins Bloomberg School of Public Health

Lewis R. Goldfrank, M.D.
Director, Emergency Medicine
Bellevue Hospital Center
Professor, Clinical Medicine and Surgery
New York University School of Medicine

Kjell Asplund, M.D., Ph.D.
Head, Department of Medicine
University Hospital
Umea, Sweden

Vicki Stover Hertzberg, Ph.D.
Associate Professor
Department of Biostatistics
Emory University