医学
临床试验
冲程(发动机)
急性中风
药物开发
重症监护医学
替代医学
物理疗法
药品
药理学
内科学
病理
机械工程
组织纤溶酶原激活剂
工程类
出处
期刊:Stroke
[Ovid Technologies (Wolters Kluwer)]
日期:2005-07-15
卷期号:36 (8): 1808-1813
被引量:157
标识
DOI:10.1161/01.str.0000173403.60553.27
摘要
Previous Stroke Therapy Academic Industry Roundtable (STAIR) meetings focused on preclinical evidence of drug efficacy and enhancing acute stroke trial design and performance. A fourth (STAIR-IV) was held to discuss relevant issues related to acute stroke drug development and regulatory approval.The STAIR-IV meeting had 3 main focus areas. The first topic was novel approaches to statistical design of acute stroke trials and appropriate outcome measures. The second focus was the need for better cooperation among participants in stroke therapy development that may be addressed through a national consortium of stroke trial centers in the United States and elsewhere. Lastly, regulatory issues related to the approval of novel mono and multiple acute stroke therapies were discussed.The development of additional acute stroke therapies represents a large unmet need with many remaining challenges and also opportunities to incorporate novel approaches to clinical trial design that will lead to regulatory approval. The STAIR-IV meeting explored new concepts of trial methodology and data analysis, initiatives for implementing a US clinical trialist consortium, and pertinent regulatory issues to expedite approval of novel therapies.
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