title: Use of remote centralized raters via live 2-way video in a multicenter clinical trial for schizophrenia.
abstract: Factors associated with clinician assessment may play a role in the increasing rate of failed trials. The use of centralized raters, a small group of highly skilled, tightly calibrated, and continuously monitored raters linked to the study sites through videoconferencing can address these issues by reducing the sheer number of raters involved, using rigorous calibration procedures not logistically feasible with a larger dispersed group of raters, and by blinding raters to visit and protocol. This phase 2 study was the first randomized controlled trial to use centralized raters in a study of treatments for schizophrenia. Subjects (N = 313) from 32 sites were randomly assigned to 6 weeks of treatment with 1 of 2 doses of an investigational antipsychotic, olanzapine 15 mg, or placebo. Subjects were evaluated weekly using the Positive and Negative Syndrome Scale. Data from the olanzapine (n = 68) and placebo (n = 68) arms were provided by the sponsor. The mean Positive and Negative Syndrome Scale change was significantly greater with olanzapine (-15.2) than placebo (-4.43), P = 0.002. The significant difference was apparent at week 1. The effect size was 0.48. Internal consistency was high throughout the study. Scores at screening were normally distributed and not skewed toward the cutoff score. Results found that hospitalized patients with schizophrenia were willing and able to participate in clinical trials using remote interviews conducted via videoconference. This methodology shows enormous promise for use in clinical trials, even with acutely psychotic patients.
authors.affiliation: Wyeth Research, Collegeville, PA, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Shen
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Kobak
authors.forename: Yonggang
authors.initials: Y
authors.lastname: Zhao
authors.forename: Madeline M
authors.initials: MM
authors.lastname: Alexander
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D015588:Observer Variation; D000077152:Olanzapine; D011569:Psychiatric Status Rating Scales; D015203:Reproducibility of Results; D012107:Research Design; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D017216:Telemedicine; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D049269:Videoconferencing; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine