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Abstract

Summary Objective To evaluate the specific components of setting up a simple multicentre clinical study four years after the new UK law on clinical trials was implemented in 2004. Design Timelines associated with activating a randomized multicentre trial in lung cancer patients using an investigational medicinal product (statins) were prospectively recorded. Setting 84 trial centres in the UK. Main outcome measures The time taken to go through the three stages necessary to activate a trial at a centre was examined: that is, the time from when Site Specific Information was electronically transferred to a participating centre until local research ethics committee (LREC) or research and development (R&D) approvals were obtained, and a signed ClinicalTrials Site Agreement (CTSA) was received. Results It took at least six months to obtain LREC approval in 21% of centres and R&D approval in 52% of centres.Twelve centres (14%) took at least 12 months to obtain R&D approval. 31% of centres took at least three months to return a signed CTSA. Although 52% of centres took at least six months to be activated, 13% were able to complete all three stages in two months or less. Conclusions While some centres can activate trials relatively quickly, there is considerable variation the time taken to set up a trial, much of which is due to the delay in obtaining R&D approval.This is having a major adverse effect on UK health research.There is a national need to streamline the process for considering multi-centre non-commercial clinical trials, in particular, having fixed timelines for R&D assessment. Without this, the costs of trials will increase because of extended duration, and the time to answer a research question and alter clinical practice will be significantly prolonged.