Science 37 was approached by NRx Pharmaceuticals to assist with the enrollment and conduct of their Phase 2B/Phase 3 treatment study of Bipolar Depression with Suicidal Ideation. Working concurrently as recruitment activity continued at 12 traditional study sites, Science 37 was challenged with helping NRx reach a goal of 74 randomized subjects. To achieve its enrollment contribution, Science 37 worked with NRx to make DCT adaptions to the study protocol, so that Science 37 could perform as a Direct-to-Participant Site (the Science 37 MetasiteTM).
Leveraging Science 37’s DCT capabilities, investigators administered all the clinical assessment measures, including the Barnes Akathisia Rating Scale (BARS), via telemedicine. For this scale, Science 37 mobile research-trained nurses made in-home visits, positioning the camera to allow visualization of the subject for assessment of objective signs of akathisia. Psychiatric symptom endpoints (clinician-reported outcomes) were also assessed via telemedicine by Science 37’s highly experienced centralized rater team.
Download the poster for an in-depth look at the study design and protocol adaptations that enabled this successful partnership.
Authors
Christopher Reist, MD
Medical Director, Psychiatry and Behavioral Sciences
Science 37
Jason Bain, MS
Senior Clinical Research Site Manager
Primary Rater of Psychiatry and Behavioral Sciences
Science 37
Jonathan Javitt, MD
Chief Scientist
NRx Pharmaceuticals, Inc.
Michael Sapko
Director of Medical Writing
NRx Pharmaceuticals, Inc.
Heather Lothamer
Associate Director of Clinical Operations
NRx Pharmaceuticals, Inc.