Skip to main content


Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays

Article metrics

  • 885 Accesses


The challenges of quickly obtaining the necessary research approvals to open multisite clinical trials in the UK, is well documented.

This presentation takes a fresh, in depth look at the factors currently limiting the efficient set up of multicentre clinical trials. We seek to discover whether newly imposed timeframes and penalties aimed at improving the speed of local NHS R&D governance checks have had the desired impact, and if so, what other activities are impacting the time taken to open research sites.


We present a case study of two trials, SANADII, a CTIMP trial aiming to recruit 1500 participants across 100+ sites and BASICS, a medical device trial, aiming to recruit 1200 participants over 17 sites. Both trials seek to have research sites across all four UK constituent nations.

Primary, secondary and tertiary delays affecting progress were recorded for sites from ethical approval to opening to recruitment. Key milestones such as SSI submission, gaining R&D approval, signing contracts and initiation training were also recorded for each site along with overarching trial milestones.

We identified sites that encountered significant delays for further analysis, looking at which milestones and activities regularly contributed to delays.


Early data suggests local research governance checks may no longer be such a limiting factor, but that other administration, document collection, and accessibility of research staff contribute significant delays.

Full analysis of the results will be presented with suggestions of how clinical trial governance should be developed to minimise impact of the reoccurring delays identified.

Author information

Correspondence to Anna Kearney.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Williamson, P., Gamble, C., Kearney, A. et al. Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays. Trials 14, O59 (2013) doi:10.1186/1745-6215-14-S1-O59

Download citation


  • Medical Device
  • Early Data
  • Research Staff
  • Research Site
  • Significant Delay


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.