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.
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.
Authors: Victoria E O'Collins; Malcolm R Macleod; Geoffrey A Donnan; David W Howells Journal: J Cereb Blood Flow Metab Date: 2012-02-01 Impact factor: 6.200
Authors: Emily S Sena; Catherine L Briscoe; David W Howells; Geoffrey A Donnan; Peter A G Sandercock; Malcolm R Macleod Journal: J Cereb Blood Flow Metab Date: 2010-07-21 Impact factor: 6.200
Authors: R Loch Macdonald; Blessing Jaja; Michael D Cusimano; Nima Etminan; Daniel Hanggi; David Hasan; Don Ilodigwe; Hector Lantigua; Peter Le Roux; Benjamin Lo; Ada Louffat-Olivares; Stephan Mayer; Andrew Molyneux; Audrey Quinn; Tom A Schweizer; Thomas Schenk; Julian Spears; Michael Todd; James Torner; Mervyn D I Vergouwen; George K C Wong; Jeff Singh Journal: Transl Stroke Res Date: 2013-01-07 Impact factor: 6.829
Authors: Daniel C Morris; Wing Lee Cheung; Richard Loi; Talan Zhang; Mei Lu; Zheng G Zhang; Michael Chopp Journal: Neurosci Lett Date: 2017-08-31 Impact factor: 3.046