Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable
Authors
Fisher, MarcAlbers, Gregory W.
Donnan, Geoffrey A.
Furlan, Anthony J.
Grotta, James
Kidwell, Chelsea S.
Sacco, Ralph L.
Wechsler, Lawrence R.
Document Type
Journal ArticlePublication Date
2005-07-16Keywords
Brain IschemiaClinical Trials as Topic
Disease Management
Drug Approval
*Health Planning Guidelines
Humans
Research Design
Stroke
Thrombolytic Therapy
Treatment Outcome
Life Sciences
Medicine and Health Sciences
Metadata
Show full item recordAbstract
BACKGROUND: 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. SUMMARY OF REVIEW: 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. CONCLUSIONS: 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.Source
Stroke. 2005 Aug;36(8):1808-13. Epub 2005 Jul 14. Link to article on publisher's siteDOI
10.1161/01.STR.0000173403.60553.27Permanent Link to this Item
http://hdl.handle.net/20.500.14038/38811PubMed ID
16020764Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1161/01.STR.0000173403.60553.27