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Assessing site performance in the Altair study, a multinational clinical trial
Nisha Berthon-Jones1, Kymme Courtney-Vega2, Anna Donaldson3
1The Kirby Institute, University of New South Wales, Kensington, NSW, 2033, Australia. nberthon-jones@kirby.unsw.edu.au.
Trials
|April 16, 2015
Summary
Clinical trial site performance varies by region, with Australia and Latin America showing faster site opening and recruitment, respectively. Accurate feasibility assessments are crucial for selecting sites to reduce trial delays and costs.
Area of Science:
- Clinical trial management
- HIV research
- Global health studies
Background:
- Investigated clinical trial site performance across 5 geographical regions.
- Included 36 sites and 322 HIV-infected individuals.
Purpose of the Study:
- Identify strategies to control clinical trial outcomes.
- Analyze regional performance variations in site opening, recruitment, and data quality.
Main Methods:
- Descriptive analysis of site opening times, recruitment rates, data collection (EDC), and serious adverse event (SAE) reporting.
- Compared performance across Asia, Australia, Europe, North America, and Latin America.
Main Results:
- Australia had the fastest site opening (177 days) and Europe the slowest (265 days).
- Recruitment exceeded forecasts only in Latin America (104%), while others were below (Asia 89%, Australia 77%, Europe 91%, North America 43%).
- Electronic data collection (EDC) and SAE reporting times varied by region, with Asia and Latin America showing faster EDC and SAE submission, respectively.
Conclusions:
- Population availability and regulatory approval timelines significantly impact recruitment.
- Accurate feasibility assessments are critical for effective site selection.
- Addressing potential delays can decrease overall clinical trial duration and costs.
