Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan.
The need for improved clinical outcome measures in multiple sclerosis trials has been recognized for two decades, but only recently has the Food and Drug Administration (FDA) created a pathway for qualification of new clinician-reported outcome (ClinRO) assessments. Additionally, drug development in multiple sclerosis (MS) has been extraordinarily active, with numerous disease-modifying drugs now on the market. This shifting therapeutic landscape, along with the unmet need for drugs to treat the progressive forms of MS and the changing expectations of clinicians, patients, and payers, have led to the call for more sensitive and meaningful disability progression measures. In response to these drivers, the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was launched. A public-private partnership, MSOAC aims to accelerate the development of new therapies for MS by generating new tools for measuring outcomes in clinical trials. At the first annual MSOAC/FDA meeting, a regulatory path was outlined for qualifying a new tool for assessing efficacy in registration trials of MS. The European Medicines Agency (EMA) and FDA will provide parallel consultation and review. The consensus approach with engagement by all of the stakeholders, prominently including patients with MS, should also increase acceptance of the measure by clinicians and patients.
Mellen Center, Cleveland Clinic Foundation, USA.
Richard A
RA
Rudick
Nicholas
N
Larocca
Lynn D
LD
Hudson
D006265:Health Care Coalitions / Q000458:organization & administration*; D006801:Humans; D009103:Multiple Sclerosis; D017063:Outcome Assessment, Health Care; D014481:United States
Outcome assessments; disability; progressive mutiple sclerosis; regulatory science