There are a number of collaborative working models for trials running on an international level.

Model 1

Model 2

Model 3


One host institution/sponsor within the UK responsible for co-ordinating the trial and co-ordinating both UK and international research sites

One host institution/sponsor within the UK responsible for co-ordinating the trial and co-ordinating UK sites only. Use of a local spoke/CRO/lead site to co-ordinate international sites.

The same or very similar protocols. Two or more host institutions each responsible for co-ordinating the trial and sites locally, feeding into a single trial analysis

Case Studies


  • Greater control over the development and co-ordination of the trial, including data management
  • Trial can be run entirely in line with host institution SOPs and guidelines
  • No spoke costs
  • Local spoke provides expertise in local regulatory and ethical environments
  • Potential reduction in contracts if spoke contract with international research sites
  • Local spoke will undertake work relating to obtaining local approvals, meaning the UK host/sponsor does not need to do this.
  • Greater pool of patients to recruit from, leading to faster recruitment, analysis and dissemination timelines
  • UK funder does not need to fund international recruitment, and vice versa therefore it may be easier to obtain funding
  • Each sponsor could be responsible for local insurance, therefore a study wide policy covering all countries may not be required.
  • UK host/sponsor will not be responsible for obtaining required local approvals at international sites


  • Potential lack of awareness of local regulatory and ethical environments
  • Setting up local sites likely to be both time and resource intensive
  • Several contracts to negotiate
  • Language barrier
  • Courier/postage implications from international sites to the UK
  • Compliance of sites to unfamiliar SOP
  • If tissue samples are required to be sent to the UK, this may be difficult to implement across all sites
  • Cost
  • Spokes may work in a different way to organisations in the UK therefore may not be in agreement with host institution SOPs
  • Contract with the spoke may need to be agreed prior to starting any international site set-up
  • Trial could be at risk if one party is not able to obtain local funding, or subsequently withdraws from participating in the trial
  • It may be difficult to develop consistent protocols between the parties
  • Timelines are likely to vary between groups involved
  • Potential lack of a party with overall responsibility for the trial
  • Monitoring may be difficult to implement

Key Points for Consideration

  • Protocol development and version control
  • Responsibility for obtaining local approvals for international sites
  • Insurance
  • Training of site staff
  • Data flows and conduct
  • Trial supplies
  • Funding
  • Database access for spoke
  • Training of spoke staff
  • Protocol development and amendments across sites
  • Database development (single versus multiple)
  • Clear division of responsibilities between the collaborating parties
  • Plan for protocol development
  • Agreement on data items and development of CRFs
  • Database development (single versus multiple)
  • Who will be responsible for the final analysis
  • Publication rights