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

Alexander Ng; Aqua Asif; Kevin Keane; Simona Ippoliti; Arjun Nathan; Veeru Kasivisvanathan; ARTS UK Investigators Group

doi:10.1016/j.euf.2023.10.005

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

Eur Urol Focus. 2023 Sep;9(5):695-697. doi: 10.1016/j.euf.2023.10.005. Epub 2023 Oct 19.

Authors

Alexander Ng¹, Aqua Asif², Kevin Keane³, Simona Ippoliti⁴, Arjun Nathan², Veeru Kasivisvanathan²; ARTS UK Investigators Group

Affiliations

¹ Division of Surgery and Interventional Science, University College London, London, UK; British Urology Researchers in Surgical Training, London, UK. Electronic address: [email protected].
² Division of Surgery and Interventional Science, University College London, London, UK; British Urology Researchers in Surgical Training, London, UK.
³ British Urology Researchers in Surgical Training, London, UK; Department of Urology, St. James' Hospital, Dublin, Ireland.
⁴ British Urology Researchers in Surgical Training, London, UK; Urology Department, Hull University Teaching Hospitals, Hull, UK.

PMID: 37863739
DOI: 10.1016/j.euf.2023.10.005

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.

MeSH terms

Clinical Trials as Topic
Drugs, Investigational* / adverse effects
Hemorrhage
Humans
Multicenter Studies as Topic
Thrombosis* / prevention & control
United Kingdom

Substances

Drugs, Investigational