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Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan

Richard A Rudick1, Nicholas Larocca, Lynn D Hudson

  • 1Mellen Center, Cleveland Clinic Foundation, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|September 24, 2013
PubMed

Insights

The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) is developing new clinician-reported outcome measures for multiple sclerosis (MS) trials. This initiative aims to accelerate the development of therapies for progressive MS, improving clinical trial efficacy assessment.

Area of Science:

  • Neurology
  • Clinical Trials
  • Regulatory Science

Background:

  • The need for improved clinical outcome measures in multiple sclerosis (MS) trials has been recognized for decades.
  • The Food and Drug Administration (FDA) has recently established a pathway for qualifying new clinician-reported outcome (ClinRO) assessments.
  • Active drug development in MS and the demand for treatments for progressive forms necessitate more sensitive disability progression measures.

Purpose of the Study:

  • To accelerate the development of new therapies for MS.
  • To generate new tools for measuring outcomes in clinical trials.
  • To establish a regulatory pathway for qualifying new MS outcome assessment tools.

Main Methods:

  • Launch of the Multiple Sclerosis Outcome Assessments Consortium (MSOAC), a public-private partnership.
  • Convening of the annual MSOAC/FDA meeting to outline a regulatory path for new assessment tools.
  • Parallel consultation and review by the European Medicines Agency (EMA) and FDA.

Main Results:

  • A regulatory pathway for qualifying new clinician-reported outcome assessments in MS trials has been outlined.
  • A consensus approach involving all stakeholders, including patients, is being adopted.
  • The process aims to increase the acceptance of new measures by clinicians and patients.

Conclusions:

  • The MSOAC initiative is crucial for advancing MS drug development.
  • The established regulatory pathway, with multi-agency and stakeholder engagement, is key to qualifying new outcome measures.
  • This collaborative effort is expected to enhance the evaluation of therapeutic efficacy in MS clinical trials.
Keywords:
Outcome assessmentsdisabilityprogressive mutiple sclerosisregulatory science

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