RESUMO
BACKGROUND: Reviewing clinical trial site performance identifies strategies to control outcomes. Performance across 5 geographical regions (36 sites across Asia, Australia, Europe, North America and Latin America) was investigated in a study that randomised 322 HIV-infected individuals. METHODS: Regional performance was compared using descriptive analysis for time to site opening, recruitment, quality of data and laboratory samples. Follow-up consisted of 10 visits (96 weeks), electronic data collection (EDC) within 7 days of a visit and serious adverse events (SAEs) reported within 24 hours of site awareness. RESULTS: Median days to site opening was 250 (188 to 266), ranging from 177 (158 to 200) (Australia) to 265 (205 to 270) (Europe). Median days to ethics and regulatory approval was 182 (120 to 241) and 218 (182 to 341) days, respectively. Within regions, time to approval ranged from 187 (91 to 205) days (Australia) to 276 (175 to 384) days (Europe). Time to first randomisation ranged from 282 (250 to 313) days (Australia) to 426 (420 to 433) days (North America). Recruitment was lower than forecasted in Asia, Australia, Europe and North America at 89%, 77%, 91% and 43%, respectively. The converse was true in Latin America where despite ethics, regulatory and contractual delays, recruitment was 104% of predicted. Median days to EDC was 7 (3 to 16), ranging from 3 (1 to 16) (Asia) to 13 (8 to 14) days (North America). Median days for initial SAE submission to sponsor was 6 (2 to 20), ranging from 4 (2 to 18) (Latin America) to 24 (5 to 46) days (Australia). Sites took longer to submit final reports, overall median of 28 (7 to 91) days, ranging from 7 days (Australia) to 67 (23 to 103) days (Europe). CONCLUSIONS: Population availability and time to ethics and regulatory approvals influence recruitment; therefore accurate feasibility assessments are critical to site selection. Time to ethics and regulatory approval may not limit site inclusion if compensated by rapid recruitment. Identifying potential delays and methods for reduction can decrease time and costs for sponsors. TRIAL REGISTRATION: Clinical Trials.Gov identifier: NCT00335322. Date of registration: 8 June 2006.
