Degital transformation for advancing clinical trials

Abstract

Conducting clinical trials in amyotrophic lateral sclerosis (ALS) poses substantial challenges in both participant recruitment and data collection. Rapid disease progression often limits mobility and functional communication, which can hinder study visits, ongoing participation, and timely provision of informed consent. In this context, “healthcare digital transformation (Healthcare DX)” and “clinical trial DX”―approaches that are increasingly being adopted or piloted internationally―remain insufficiently integrated into routine clinical practice in Japan. Nevertheless, phased implementation of these approaches is underway, given their potential to mitigate these barriers, enhance participant engagement, improve data quality, and reduce development costs. Collectively, these efforts are expected to establish a strategic foundation for future therapeutic development in ALS.