CLINICAL trials, CLINICAL governance, MEDICAL research, UNIVERSITY research, ETHICS
Abstract
A recent study conducted by researchers at the University of New South Wales Sydney explored the factors that influence the time it takes to obtain ethics and governance approvals for multi-center clinical trials. The study analyzed data from 150 site activations across 91 sites, 16 trials, and 5 countries. The findings revealed that the overall median time to site activation was 234 days, with ethics approval taking a median of 48 days and governance approval a median of 34 days. Factors such as disease area, use of scope guidelines, and a triage process were associated with shorter approval times. The study suggests that the introduction of certain governance and ethics processes can help reduce approval times. [Extracted from the article]
Published
2023
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