The Clinical Trials Research Unit (CTRU) at the University of Leeds, UK, has experience of running a number of international surgical trials, all of which faced varying and complex challenges during set-up and implementation resulting in significant delays to timelines. With these issues in mind, the CTRU successfully bid for funding from a call issued by the UK’s National Institute for Clinical Research (NIHR) which focussed on supporting efficient/innovative delivery of clinical trials. The funding enabled the development of this international trials toolkit for use by UK researchers, to guide the efficient set-up and conduct of international surgical trials and therefore improve the delivery of research.
The toolkit project is led by the Leeds CTRU in collaboration with CTEU Bristol & Birmingham CTU and brings together expertise from other UK based clinical trials units with experience of running international surgical trials. The toolkit content is based on the obstacles and successes encountered by these CTUs in coordinating and delivering international trial collaborations from the UK.