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Related Experiment Videos

MS clinical trial design for the future

D E Goodkin1

  • 1UCSF/MT Zion Multiple Sclerosis Center 94115, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|July 1, 1996
PubMed
Summary
This summary is machine-generated.

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Developing new composite outcomes for multiple sclerosis (MS) clinical trials will improve sensitivity and reliability. Magnetic resonance imaging (MRI) measures like T2 lesion burden show promise for relapse-prone patients.

Area of Science:

  • Neurology
  • Clinical Trials
  • Medical Imaging

Background:

  • The Clinical Outcomes Task Force is developing new composite outcomes for multiple sclerosis (MS) clinical trials.
  • Existing outcomes need to be more sensitive, reliable, validated, and capture the diverse dimensions of MS.
  • The Task Force on Use of MRI in MS Clinical Trials has issued recommendations for magnetic resonance imaging (MRI) in MS studies.

Purpose of the Study:

  • To develop easily administered composite outcomes for MS clinical trials.
  • To enhance the measurement of independent dimensions of MS.
  • To improve the utility of MRI in MS clinical trials.

Main Methods:

  • Reviewing and synthesizing recommendations from the Task Force on Use of MRI in MS Clinical Trials.

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  • Identifying specific MRI measures, such as T1 gadolinium-enhancing (T1Gd+) lesions and changes in T2-weighted (T2W) lesion burden.
  • Focusing on composite outcomes and advanced statistical methods.

    • Main Results:

    • T1Gd+ activity and changes in T2W lesion burden are identified as potentially useful outcomes for patients with recent frequent relapses.
    • Anticipation of improved predictive validity for MR imaging techniques through enhanced composite outcomes and statistical methods.

    Conclusions:

    • Improved composite outcomes and validated MRI measures can enhance the efficiency of MS clinical trials.
    • Future definitive trials may require fewer patients and be conducted more expeditiously.
    • The development of sensitive, reliable, and validated outcomes is crucial for advancing MS research.