Amyotrophic lateral sclerosis: lessons in trial design from recent trials

被引:8
作者
Borasio, GD
机构
关键词
amyotrophic lateral sclerosis; trial design; comparability; disease progression; quality of life;
D O I
10.1016/S0022-510X(97)00240-2
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The recent history of clinical trials in ALS is marked by a great diversity in trial design. This has limited the comparability of the trial results, and has resulted in intense discussions about which parameters should or should not be evaluated when testing a new drug for ALS. This article discusses, without any claim to completeness, some aspects of trial design in relation to past, ongoing and future ALS trials, including: choice of endpoints, measurement of disease progression, assessment of quality of life, placebo-controlled trials, open-label trials, collaboration with the industry, and methods for investigating mechanisms of action of experimental drugs. (C) 1997 Elsevier Science B.V.
引用
收藏
页码:S23 / S28
页数:6
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