Acute stroke therapy trials: problems in patient accrual

Temple University Hospital participated in a multicenter acute stroke trial but enrolled only one patient out of 192 screened over 2 years; other centers had similar difficulty in patient recruitment. We analyzed our screening data to determine which enrollment criteria created difficulties in recruitment and whether the problem was attributable to any single criterion or to combinations of criteria. Six individual criteria were frequent causes for exclusion; however, greater than 80% of the patients were excluded for multiple reasons. Consequently, modifying or eliminating any single criterion did not appreciably increase patient accrual. Only 17 of 210 possible pairs of criteria occurred with statistically significant frequency (p less than 0.05), and these were most likely random associations. Therefore, only by minimizing the number and stringency of enrollment criteria will patient accrual be at a level that allows the study to be completed in a timely manner with a fiscally reasonable number of centers.