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Acute stroke therapy trials: problems in patient accrual
L J LaRue1, M Alter, N D Traven
1Neuroepidemiology Section, Temple University Hospital, Philadelphia, Pennsylvania 19140.
Stroke
|August 1, 1988
Summary
Recruiting patients for acute stroke clinical trials is challenging due to strict enrollment criteria. Simplifying criteria is essential for timely and cost-effective study completion.
Area of Science:
- Neurology
- Clinical Trials
- Medical Research
Background:
- Multicenter acute stroke trials face significant patient recruitment challenges.
- Temple University Hospital enrolled only one patient out of 192 screened over two years, indicating widespread recruitment issues.
Purpose of the Study:
- To analyze screening data to identify problematic enrollment criteria in acute stroke trials.
- To determine if single or multiple criteria contribute to low patient accrual.
Main Methods:
- Screening data from a multicenter acute stroke trial was analyzed.
- Statistical analysis was performed to identify frequent exclusion criteria and their combinations.
Main Results:
- Six individual criteria frequently caused patient exclusion.
- Over 80% of patients were excluded for multiple reasons, not single criteria.
- Modifying single criteria did not significantly improve patient enrollment.
Conclusions:
- Low patient accrual in acute stroke trials is primarily due to multiple, stringent enrollment criteria.
- Minimizing the number and stringency of criteria is crucial for timely and fiscally responsible trial completion.