2024
DOI: 10.1212/wnl.0000000000209533
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Prevalence and Impact of Bypassing or Overriding Phase 2 Trials in Neurologic Drug Development

Hannah Moyer,
Robyn Mellett,
Karine Vigneault
et al.

Abstract: Background and ObjectivesPivotal trials for neurologic drugs in clinical development are often initiated without a phase 2 trial ("bypass") or despite a negative phase 2 efficacy result ("override"). Such practices may degrade the risk/benefit ratio of phase 3 trials. The aim of this study is to estimate the proportion of phase 3 trials for 10 neurologic diseases started without a positive phase 2 trial, to identify factors associated with this practice, and to investigate any association with unfavorable phas… Show more

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