So this is where Dr. Michael Tymianski of the
Toronto Western Hospital Research Institute
in Canada referencing 1000+ failed neuroprotective clinical trials got his information.Of course this is useless since every stroke researcher will need to go thru this to make sure their research hasn't already been done and failed. Precisely why we need a stroke strategy and stroke leadership.
Abstract
OBJECTIVE:
Preclinical
evaluation of neuroprotectants fostered high expectations of clinical
efficacy. When not matched, the question arises whether experiments are
poor indicators of clinical outcome or whether the best drugs were not
taken forward to clinical trial. Therefore, we endeavored to contrast
experimental efficacy and scope of testing of drugs used clinically and
those tested only experimentally.
METHODS:
We identified
neuroprotectants and reports of experimental efficacy via a systematic
search. Controlled in vivo and in vitro experiments using functional or
histological end points were selected for analysis. Relationships
between outcome, drug mechanism, scope of testing, and clinical trial
status were assessed statistically.
RESULTS:
There was no
evidence that drugs used clinically (114 drugs) were more effective
experimentally than those tested only in animal models (912 drugs), for
example, improvement in focal models averaged 31.3 +/- 16.7% versus 24.4
+/- 32.9%, p > 0.05, respectively. Scope of testing using Stroke
Therapy Academic Industry Roundtable (STAIR) criteria was highly
variable, and no relationship was found between mechanism and efficacy.
INTERPRETATION:
The
results question whether the most efficacious drugs are being selected
for stroke clinical trials. This may partially explain the slow progress
in developing treatments. Greater rigor in the conduct, reporting, and
analysis of animal data will improve the transition of scientific
advances from bench to bedside.
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