Recruiting subjects for acute stroke trials: a meta-analysis

Area of Science:

• Neurology
• Clinical Trials
• Medical Research

Background:

• Recruitment rate significantly impacts the duration, cost, and feasibility of acute stroke trials.
• Efficient patient enrollment is crucial for the successful execution of clinical research in acute ischemic stroke.

Purpose of the Study:

• To conduct a meta-analysis of randomized, controlled trials evaluating medical interventions for acute ischemic stroke.
• To identify factors influencing recruitment efficiency in these trials.

Main Methods:

• Meta-analysis of 32 randomized, controlled trials with >=300 subjects.
• Independent abstraction of trial data on recruitment, organization, and entry criteria.
• Definition of recruitment efficiency as subjects enrolled per study center per month.

Main Results:

• Average recruitment efficiency was 0.79 subjects/center/month.
• Single-country trials showed higher efficiency than international studies (P=0.03).
• Longer treatment windows (>6 hours) doubled recruitment rates compared to shorter windows (<=6 hours).
• Exclusion of mild strokes and shorter time from stroke to enrollment reduced efficiency.

Conclusions:

• Organizational structure and study entry criteria are key predictors of recruitment rates in acute stroke trials.
• Optimizing trial design by understanding these predictors can enhance future research efficiency.