If running a trial involving international patient recruitment, the impact on costs should be carefully considered upfront as international recruitment can entail additional costs beyond that required for recruitment solely of UK patients.. Impact on resources and overall cost will depend on the collaborative model of working chosen, or indeed may drive the decision to which collaborative model is chosen.

UK grant funders are now more receptive to funding international recruitment (where required) in clinical trials, however this does vary from funder to funder. It is recommended that funding terms and conditions are fully explored at the outset which may include obtaining an agreement in principal to what can be funded by the funder. Where a funder is receptive funding for international recruitment, justification for this should be clearly detailed within the grant application. Reasons for requiring international recruitment may include:
  • Limited UK sites that could take part in a trial. This could be due to the requirement for certain surgical equipment, a minimum level of surgeon operating experience or trial interventions only performed by specialist centres.
  • Known small participant population
If UK funding is not available, alternative funding could potentially be found from funding sources local to participating international spokes/sites. This however may impact which collaborative working model chosen for the trial depending on individual funder terms and conditions and whether they would be receptive to being involved as a co-funder. Involvement of more than one funder can pose an additional risk to delivery of the trial if one funding application is not successful, or is later withdrawn.