Recruiting subjects for acute stroke trials: a meta-analysis

Abstract

Background and purpose: Recruitment rate is a major determinant of the duration, cost, and feasibility of acute stroke trials.

Methods: We performed a meta-analysis of all randomized, controlled trials of > or =300 subjects that were designed to evaluate the efficacy of a medical intervention for the treatment of acute ischemic stroke. Data about trial recruitment, organization, and inclusion/exclusion criteria were abstracted independently by 2 reviewers who applied predefined criteria. Recruitment efficiency was defined as the number of subjects enrolled per study center per month of recruitment.

Results: Of 32 trials meeting inclusion criteria, the average recruitment efficiency was 0.79 subjects per center per month (range 0.08 to 3.7). Recruitment efficiency did not vary by geographic region (P=0.36), but trials conducted in 1 country had more efficient recruitment than international studies (P=0.03), and recruitment efficiency declined with each percentage increase in the total number of study centers (P=0.002). The primary study entry criteria that predicted reduced recruitment efficiency were the maximum allowable time from stroke to study enrollment (P=0.002) and the exclusion of mild strokes (P=0.009). Trials with a treatment window >6 hours had approximately double the recruitment rates of trials that used treatment windows < or =6 hours (1.03 versus 0.52 patients per center per month).

Conclusions: Recruitment rates for acute stroke trials are influenced by organizational structure and study entry criteria. Characterizing predictors of recruitment may help optimize future trial design.