Amyotrophic lateral sclerosis: lessons in trial design from recent trials.

Abstract:

: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.

journal_name

J Neurol Sci

authors

Borasio GD

doi

10.1016/s0022-510x(97)00240-2

subject

Has Abstract

pub_date

1997-10-01 00:00:00

pages

S23-8

eissn

0022-510X

issn

1878-5883

pii

S0022-510X(97)00240-2

journal_volume

152 Suppl 1

pub_type

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