Halving Effort in Acute Stroke Trials

Abstract

The expense and substantial effort required to conduct multicenter acute stroke trials are potentially limiting factors for progress in this field. To facilitate future work, we need to expand on collaborative approaches to learn from existing trial data sets, for example, using the Virtual International Stroke Trials Archive. Using these networks, we can identify ways of reducing future effort in trials. The interaction between two or more selection criteria can be considered and can allow trials to concentrate on the most informative patients. This has the potential to shorten the recruitment period and increase power simultaneously. Through enhanced training and certification of investigators in assessing outcomes, the main outcome measures may be assessed more accurately. This also should enhance study power. The choice of outcome scale and its method of analysis can have a profound effect on trial power and likely success. The Rankin scale may have advantages over the Barthel index. By combining these various approaches, acute stroke trials can be much more efficient.

Keywords:

• acute stroke
• clinical trial
• neuroprotection
• outcome measure
• sample size
• variability