This is exciting. iTakeControl, our comprehensive mobile platform for decentralized research trials, evidence-based research, telehealth, and learning programs, has been used in the field.
Here is an excerpt from the decentralized clinical trial summary in Springer.
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
Authors: Xinruo Zhang MS, Katherine Brind’Amour PhD, Kelly E. King PhD, LP, ABPP-CN, Susan Hartmaier PhD, Katherine Harris DrPH, David A. Weinstein MD, MMSc & Cynthia J. Girman DrPH, FISPE
Abstract
Introduction:
Neurodegenerative diseases cause developmental delays and loss of milestones in infants and children. However, scalable outcome measures that quantify features meaningful to parents/caregivers (P/CGs) and have regulatory precedence are lacking for assessing the effectiveness of treatments in clinical trials of neurodegenerative disorders. To address this gap, we developed an innovative, blinded strategy for single-arm trials with external controls using expert panel review of home video.
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P/CGs prompted and recorded activities by their child in a standardized fashion using a smartphone. The P/CG training materials had a brief manual for the study’s corresponding smartphone app (iTakeControl, RedNucleus, Yardley, PA), which included training videos for each selected activity. A laminated quick reference guide outlining exactly what to do for each activity and providing tips for improving video quality (e.g., avoid filming in front of a window to minimize glare) was also provided (Supplementary Fig. 1). Each of the six skillsets included several basic standardized instructions regarding camera distance, position of child, actions to take during the video, skills being looked for, and examples of how the P/CG could elicit these activities from their children (Fig. 1, Supplementary Fig. 1).
Read more at Springer: Therapeutic Innovation & Regulatory Science