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Late-starter sites in randomized controlled trials
Anna-Bettina Haidich1, John P A Ioannidis
1Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, 45110, Ioannina, Greece.
Journal of Clinical Epidemiology
|June 19, 2003
Summary
Early enrolling sites are crucial for clinical trial success. Inefficient late-starter sites rarely contribute significantly to patient accrual in large, fixed-site trials, suggesting administrative efforts to add them later are often unproductive.
Area of Science:
- Clinical Trials
- HIV/AIDS Research
- Multicenter Study Design
Background:
- The Adult AIDS Clinical Trials Group (AACTG) conducted 14 randomized controlled trials (RCTs) between 1986 and 1999.
- Evaluating patient accrual contributions from 'late-starter' clinical trial sites was the focus.
Purpose of the Study:
- To assess the impact of late-starting clinical trial sites on overall patient enrollment.
- To determine the efficiency of adding new sites to multicenter trials after initiation.
Main Methods:
- Analysis of 14 AACTG randomized controlled trials with over 400 target sample size each.
- Examined enrollment data from sites starting recruitment within 5 months versus later.
- Total enrollment across trials was 15,531 patients.
Main Results:
- Sites initiating recruitment within 5 months accounted for over 90% of total enrollment in 11 of 14 trials.
- Consistent differences observed between early and late-starting sites across trials.
- Late-starter sites made minimal contributions to overall patient accrual.
Conclusions:
- Late-starter sites are unlikely to significantly contribute to patient enrollment in large, fixed-site clinical trials.
- Extending administrative efforts to add sites late in a trial's timeline may not enhance accrual.
- Optimizing early site activation is critical for efficient multicenter trial recruitment.