BCI Society Workshop Tackles Outcome Measures for Pivotal Trials
A workshop at the BCI Society Meeting 2025, run with the Implantable BCI Collaborative Community (iBCI-CC), took up how clinical outcome assessments (COAs) for pivotal BCI trials should be selected, developed and validated. Participants pointed to patient heterogeneity, the absence of widely validated COAs, and the difficulty of capturing outcomes that matter in home and daily-life settings. The discussion lays groundwork for the iBCI-CC Clinical Study Endpoints Workgroup to build a transparent process for identifying meaningful aspects of health and concepts of interest, in support of regulatory approval and reimbursement.