This week, the Journal of Clinical Neurophysiology published a special issue about recent innovations and their regulatory implications for clinical trials in multiple sclerosis. Dr. Mark Skeen, Senior Medical Scientist at VeraSci and Professor of Neurology at Duke University Medical Center served as a guest editor and contributor for the issue.
The issue includes the article “Biomarkers and Surrogate Endpoints in Multiple Sclerosis Clinical Trials: Regulatory Issues” co-authored by Dr. Skeen and Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci and former Director-General of the Italian Medicines Agency (AIFA).
Evoked potentials have long played a role in the diagnosis of Multiple Sclerosis (MS), but have recently gained attention as a possible outcome measure for use in clinical trials. Like any surrogate endpoint, evoked potentials must demonstrate their precision and reproducibility, the settings in which they are meaningful, and the degree to which they predict clinically significant outcomes to gain acceptance with regulatory agencies and payers in the further evaluation of a product’s potential for reimbursement. This article explores regulatory issues associated with using evoked potentials as biomarkers and surrogate endpoints for use in clinical trials.
The issue also includes the article “Changing Paradigms and Unmet Needs in Multiple Sclerosis: The Role of Clinical Neurophysiology” authored by Dr. Skeen which reviews the change in the understanding of MS over past years with the focus on axonal loss, remyelination, and progressive MS (read more here). Dr. Skeen also contributed an editorial entitled “The Use of Evoked Potentials in Multiple Sclerosis Clinical Trials” (read more here).