Recent findings from a National Multiple Sclerosis (MS) Study estimate that nearly 1 million people in the US are living with MS, a number that has more than doubled since it was last reported in 1975. We at VeraSci are committed to helping our clients drive therapies forward to help patients suffering with this debilitating disease. Senior Medical Scientist, Mark Skeen, MD, and Senior Director of Neurosciences, Heather Snyder, PhD are using their expertise and knowledge to enhance research identifying treatment options for this widespread disabling neurological condition.
In the past, Multiple Sclerosis clinical trial endpoints have focused primarily upon measures of disease activity rather than patient-reported outcomes. There is a growing desire, especially from regulatory bodies, to inform endpoints measuring disease activity with the patient’s perspective on treatment interventions. We know from a conjoint analysis conducted by Wilson, L., et al. (2014) that patients with Multiple Sclerosis are willing to accept significant therapeutic risk if they can reasonably expect improvement in their symptoms.
To address the need for a patient-centric account of symptomatology throughout the course of a clinical trial, a sponsor requested that VeraSci develop an iPad-based assessment to monitor patients’ perspective on how much emotional or psychological distress their symptoms cause them. VeraSci answered this call with the Multiple Sclerosis Individual Outcome Assessment (MSIOA), a Pathway eCOA-based structured interview designed for this purpose in the VeraSci Innovation Lab. The MSIOA is being utilized in two large Multiple Sclerosis therapeutic trials and will be administered at visits throughout the trial. The frequency and severity of distress is captured for any MS-related symptom the patient has experienced within a two-week period and is tracked over time. The MSIOA focuses on identifying those symptoms that are most bothersome to the patient and tracks their frequency and severity of associated distress.
The development and use of the MSIOA highlights an exciting advancement towards increased sensitivity to, and measurement of, patient-centered symptom outcomes in MS research.
Wilson, L., Loucks, Al, Bui, C., et al. (2014). Patient centered decision making: use of conjoint analysis to determine risk-benefit trade-offs for preference sensitive treatment choices. J Neurol Sci, 344(1-2): 80-87.