Recommendations for clinical trial evaluation of acute stroke therapies - Stroke Therapy Academic Industry Roundtable II (STAIR-II)

被引：180

作者：

Albers, GW ^{[1
]}

Bogousslavsky, J ^{[1
]}

Bozik, MA ^{[1
]}

Brass, LM ^{[1
]}

Broderick, JP ^{[1
]}

Fisher, M ^{[1
]}

Goldstein, LB ^{[1
]}

Salazar-Grueso, E ^{[1
]}

Akitsuki, S ^{[1
]}

Aranko, K ^{[1
]}

Ashwood, T ^{[1
]}

Atkinson, RP ^{[1
]}

Bell, RD ^{[1
]}

Brott, TG ^{[1
]}

Cady, WJ ^{[1
]}

Caplan, LR ^{[1
]}

Coggins, S ^{[1
]}

Cramer, S ^{[1
]}

Cyrus, P ^{[1
]}

Dayno, J ^{[1
]}

Easton, JD ^{[1
]}

Elliott, PJ ^{[1
]}

Finklestein, SP ^{[1
]}

Furlan, AJ ^{[1
]}

Gamzu, E ^{[1
]}

Glasky, MS ^{[1
]}

Gordon, K ^{[1
]}

Gorelick, PB ^{[1
]}

Greenwood, DT ^{[1
]}

Grotta, JC ^{[1
]}

Gunn, K ^{[1
]}

Hachinski, V ^{[1
]}

Hacke, W ^{[1
]}

Hall, ED ^{[1
]}

Hsu, CY ^{[1
]}

Humphreys, DM ^{[1
]}

Ishikawa, H ^{[1
]}

Jacobs, AJ ^{[1
]}

Kaste, M ^{[1
]}

Koroshetz, WJ ^{[1
]}

Krams, M ^{[1
]}

Lauritano, AA ^{[1
]}

Leclerc, J ^{[1
]}

Lees, KR ^{[1
]}

Lesko, L ^{[1
]}

Levine, SR ^{[1
]}

Levy, DE ^{[1
]}

Li, FH ^{[1
]}

Lyden, PD ^{[1
]}

Masayasu, H ^{[1
]}

机构：

[1] Univ Massachusetts, Ctr Hlth, Worcester, MA 01605 USA

来源：

STROKE | 2001年 / 32卷 / 07期

关键词：

clinical trials; stroke; acute; therapy;

D O I：

10.1161/01.STR.32.7.1598

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

The development of therapies for acute ischemic stroke has achieved a few notable successes and, unfortunately, many unsuccessful efforts. Many valuable lessons for the future assessment of new acute stroke therapies can be gleaned from the positive and negative prior trials. Phase T and II trials must be carefully designed and implemented to derive relevant, valuable information needed to proceed to phase III trials with promising interventions. The phase III trial should evaluate drug efficacy in an appropriately targeted stroke population evaluated by a meaningful and reliable outcome measure. Combinations of various types-of stroke therapies will likely be increasingly assessed in future trials that are designed and implemented by cooperative: efforts between the pharmaceutical industry, government agencies, academic advisors and clinical investigators.:The chances for future success in demonstrating efficacy with:acute stroke therapies will be enhanced by Carefully conceive, scientifically based clinical trials; The recommendations contained in this document may help to focus attention on how to achieve the goal of developing an expanding number of a effective and safe acute stroke therapies.

引用

页码：1598 / 1606

页数：9

共 46 条

[1] Baseline NIH Stroke Scale score strongly predicts outcome after stroke - A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST) [J].