UMass/Memorial Healthcare Center; Department of Neurology
Brain Ischemia; Clinical Trials as Topic; Disease Management; Drug Approval; *Health Planning Guidelines; Humans; Research Design; Stroke; Thrombolytic Therapy; Treatment Outcome
Life Sciences | Medicine and Health Sciences
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.
DOI of Published Version
Stroke. 2005 Aug;36(8):1808-13. Epub 2005 Jul 14. Link to article on publisher's site
Stroke; a journal of cerebral circulation
Fisher, Marc; Albers, Gregory W.; Donnan, Geoffrey A.; Furlan, Anthony J.; Grotta, James; Kidwell, Chelsea S.; Sacco, Ralph L.; and Wechsler, Lawrence R., "Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable" (2005). Open Access Articles. 1654.