Recommendations for clinical trial evaluation of acute stroke therapies.

Journal Article (Journal Article;Review)

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 I 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 conceived, 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.

Full Text

Duke Authors

Cited Authors

  • Stroke Therapy Academic Industry Roundtable II (STAIR-II),

Published Date

  • July 2001

Published In

Volume / Issue

  • 32 / 7

Start / End Page

  • 1598 - 1606

PubMed ID

  • 11441207

Electronic International Standard Serial Number (EISSN)

  • 1524-4628

Digital Object Identifier (DOI)

  • 10.1161/01.str.32.7.1598


  • eng

Conference Location

  • United States