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Outcome measures in relapsing-remitting multiple sclerosis: capturing disability and disease progression in clinical

Amy M Lavery1, Leonard H Verhey2, Amy T Waldman3

  • 1Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.

Multiple Sclerosis International
|June 3, 2014
PubMed

Insights

Multiple sclerosis (MS) is a chronic disease impacting disability measurement in clinical trials. This review details outcome measures and surrogate endpoints for MS trials, addressing challenges in adult and pediatric study designs.

Area of Science:

  • Neurology
  • Clinical Trials
  • Neuroimmunology

Background:

  • Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease characterized by relapses and progressive disability.
  • Measuring disability progression and relapse recovery in MS clinical trials presents significant challenges due to patient variability.
  • Current outcome measures and surrogate endpoints in MS research require careful evaluation for efficacy and reliability.

Purpose of the Study:

  • To define and review the outcome measures and surrogate endpoints utilized in multiple sclerosis clinical trials.
  • To present the inherent challenges associated with designing clinical trials for both adult and pediatric MS populations.
  • To provide a comprehensive overview of assessment tools for MS clinical research.

Main Methods:

  • Literature review of established and emerging outcome measures in MS clinical trials.
  • Analysis of surrogate endpoints and their validation in assessing disease progression.
  • Examination of methodological challenges in adult and pediatric MS trial design.

Main Results:

  • A wide array of outcome measures and surrogate endpoints have been employed in MS clinical trials.
  • Significant variability exists in patient recovery and disability progression, complicating endpoint selection.
  • Challenges in MS trial design include patient heterogeneity, measurement sensitivity, and pediatric-specific considerations.

Conclusions:

  • Standardized and validated outcome measures are crucial for robust MS clinical trials.
  • Addressing the complexities of disability assessment is essential for accurately evaluating therapeutic interventions in MS.
  • Further research is needed to refine endpoints and overcome design challenges in both adult and pediatric MS studies.

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