Clinical Outcome Assessments for Trials in Cognitive Impairment Associated with Schizophrenia
Presented at the 2019 Congress of the Schizophrenia International Research Society’s (SIRS)
The co-primary approach may set a high bar for statistical significance: a modest impact of correlation between endpoints is observed on required sample size; and a more important impact of effect size is observed, with sample size determined by the smaller. In recent draft guidance for early AD, FDA acknowledge cognition as meaningful and outline circumstances in which integrated cognition-function, or cognition only outcomes would be acceptable as single primary endpoints.
Furthermore, recent Patient Focused drug development initiatives at FDA have stressed the importance of patient-caregiver input in the development of outcomes and the generation of data for drug approval.
Thus, it may be timely to review current outcomes for clinical trials of Cognitive Impairment Associated with Schizophrenia.