CRF Health and a clinical research group at the University Hospital Basel (UHB), led by Professor Ludwig Kappos, collaborated to develop an electronic Neurostatus-Expanded Disability Status Scale (EDSS) instrument for capturing clinical trial data on an electronic device. The Neurostatus-EDSS has been adopted as standard in more than 160 phase II and III clinical trials in MS and euromyelitis optica (NMO) in the last 20 years, and has been implemented in most of the pivotal trials that have led to the approval of current MS treatments. The electronic
Neurostatus-EDSS presents a new option for study teams looking to enhance their data collection in MS clinical trials. In this case study, we’ll examine how the electronic Neurostatus-EDSS replaces the way data is captured in the traditional assessment that requires EDSS raters to complete paper forms that suffer from all the typical issues with inter- and intra-rater reliability (slow review process,
limited interactivity, etc.). We’ll also review how the electronic version streamlines data collection to not only facilitate the capture of higher quality data, but reduce burden on sites and patients by significantly speeding up the process.