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Why Most Acute Stroke Studies Are Positive in Animals but Not in Patients: A Systematic Comparison of Preclinical, Early Phase, and Phase 3 Clinical Trials of Neuroprotective Agents.

Antje Schmidt-PogodaNadine BonbergMailin Hannah Marie KoeckeJan-Kolja StreckerJürgen WellmannNils-Martin BruckmannCarolin BeukerWolf-Rüdiger SchäbitzSven G MeuthHeinz WiendlHeike MinnerupJens Minnerup
Published in: Annals of neurology (2019)
Pivotal study design differences between experimental studies and clinical trials, including different primary end points and time to treatment, publication bias, neglected quality criteria and low power, contribute to the stepwise efficacy decline of stroke treatments from experimental studies to phase 3 clinical trials. Even under conservative estimates, less than half of published positive experimental stroke studies are truly positive. ANN NEUROL 2020;87:40-51.
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