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Updated: Jun 9, 2026
09:21
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Optimizing stroke clinical trial design: estimating the proportion of eligible patients
Alexis Taylor1, Amanda Castle, José G Merino
1Section on Stroke Diagnostics and Therapeutics, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland 20892-1063, USA.
Stroke
|August 28, 2010
Summary
A new model accurately estimates the proportion of stroke patients eligible for clinical trials based on age, severity, and treatment time. This tool aids in efficient clinical trial planning and site selection for acute ischemic cerebrovascular syndromes.
Area of Science:
- Neuroscience
- Clinical Research
- Biostatistics
Background:
- Accurate patient counts are crucial for clinical trial planning and site selection.
- Estimating eligible patient populations for stroke trials is complex.
Purpose of the Study:
- To develop a tool for calculating the proportion of patients meeting specific trial criteria (age, baseline severity, time to treatment).
Main Methods:
- Developed regression curves using data from 1322 acute ischemic cerebrovascular syndrome patients.
- Validated the model by comparing predicted vs. actual eligible patient proportions for four stroke trials.
Main Results:
- Predicted eligible patient proportions ranged from 6% to 28% across different trials.
- Model predictions were highly accurate, with a maximum error of 1.4%.
- Eligibility increased with National Institutes of Health Stroke Scale score and time from onset; adjustments to these parameters significantly impact eligibility.
Conclusions:
- The developed model effectively estimates stroke patient eligibility for clinical trials.
- This tool can significantly aid in clinical trial planning and site selection by providing accurate patient proportion estimates.
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