ARTs（手术中避免血栓和出血风险）试验：在英国设立国际多中心临床试验以评估一种研究药物的经验教训。
The ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) Trial: Lessons Learnt in Setting Up an International Multicentre Clinical Trial of an Investigational Medicinal Product in the UK.
机构信息
Division of Surgery and Interventional Science, University College London, London, UK; British Urology Researchers in Surgical Training, London, UK.
Division of Surgery and Interventional Science, University College London, London, UK; British Urology Researchers in Surgical Training, London, UK.
出版信息
Eur Urol Focus. 2023 Sep;9(5):695-697. doi: 10.1016/j.euf.2023.10.005. Epub 2023 Oct 19.
PMID:37863739
Abstract
We describe our experience in setting up the UK arm of the ARTS trial and highlight regulatory and funding challenges in relation to an international multicentre setting for an investigational medicinal product.
摘要
我们描述了在英国开展 ARTS 试验的经验，并强调了与一种研究性药物的国际多中心研究环境相关的监管和资金方面的挑战。
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