Assessing relapses in treatment trials of relapsing and remitting multiple sclerosis: can we do better?

被引:8
作者
Liu, C [1 ]
Blumhardt, LD [1 ]
机构
[1] Univ Nottingham Hosp, Queens Med Ctr, Fac Med, Div Clin Neurol, Nottingham NG7 2UH, England
来源
MULTIPLE SCLEROSIS | 1999年 / 5卷 / 01期
关键词
multiple sclerosis; outcome measures; treatment trials; relapsing-remitting;
D O I
10.1177/135245859900500105
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Published Phase III immunomodulatory treatment trials in relapsing and remitting multiple sclerosis have demonstrated a modest decline in attack rates, but only a minor effect on disability. As genuine disability progression is difficult to ascertain in relatively short studies with the conventional rating scales available, the acquisition and analysis of relapse data ore critical. However, there ore as yet unresolved questions related to the letter. We will first discuss the problems associated with relapse definitions by trial investigators, the paucity of the data collected (especially on the magnitude and duration of exacerbations) and statistical issues in their analysis. We will then suggest practical points for obtaining more accurate information on relapses and evaluating them meaningfully. While there is still general consensus among neurologists that primary endpoints for therapeutic trials should be clinical, improvements for future protocols ore essential.
引用
收藏
页码:22 / 28
页数:7
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