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Uncertainty remains about efficacy
| The first 150 words of the full text of this article appear below. |
EDITOR
The article by Lenzer and the associated commentary by Saver et
al raise many serious issues, among which is the residual state of
uncertainty concerning the efficacy of alteplase (tPA) in acute
ischaemic stroke.1 Confronted by opposing interpretations of the aggregate data published to date and the now known baseline imbalance in the severity of stroke in the National Institute of
Neurological Diseases and Stroke (NINDS) trial, doctors are presented
with a conundrum: what action do the data support?
The reported unwillingness of the investigators and sponsor of the
National Institute of Neurological Diseases and Stroke trial to provide
data for additional analysis is disturbing. Emanuel et al have
described seven requirements for the ethical conduct of clinical
research, among which is social and scientific value.2 Social value presupposes the public dissemination of research results.
I have formulated a standard for the scientific and ethical review of
trials