Trials with international components require additional resources, which will need to be adequately covered by the trial budget. Additional costs could include:
Project management of an international trial will be more complex than if the trial only involved UK recruitment. This may therefore require more senior oversight and input to manage the set-up of international sites particularly in relation to contract negotiations and to resolve any challenges posed by recruiting on an international level. Additional staff time may be required as international set-up is more time intensive.
International recruitment often will require additional set-up time in a grant as which will have a knock-on effect on overall grant costs. Time should be factored in to allow certain elements of set-up that may extend timelines e.g. contract negotiations and obtaining translations of documents.
There are advantages to using an international spoke/lead site for local trial co-ordination in a country or territory. Costs will depend on level of involvement in the trial, and duration of work. Responsibilities for all parties involved should be clear from the outset to ensure adequate funding is calculated and included. Trial archiving may also involve shipping of trial documents at the end of the trial to the main co-ordinating centre from international spokes/lead sites.
Dependant on the local clinical trials insurance policy held by the host institution, additional funding may be required to put in place
insurance in different countries. This should be explored early on during the grant development as costs can be high depending on the level of cover required and won’t always be covered by all funders.
In some territories, ethical committee/ institutional review boards/regulatory agencies charge fees for review of projects for initial approvals, amendments and ongoing yearly reviews. In some cases, it may be possible to have these fees waived e.g. a non-commercial trial. A clear understanding of local ethical review processes in each country will ensure that adequate funding for these types of fees can be included within the trial grant.
Local research support can differ between sites as there may not be the same research infrastructure as the UK e.g. clinical research networks etc. If sites are responsible for obtaining local approvals, can funding be included to facilitate this? Additional funding may also be required to ensure local research support throughout the trial to ensure good compliance with the trial and subsequent data collection.
If possible, site and per-patient payments should be costed in the same way as costed for UK sites. This may mean that it is easier to obtain funding for international recruitment.
Translation of patient facing documents e.g. patient information sheets, consent form documents, cover letters etc. Costs of original translations and back translations where required. There may also be additional costs associated with obtaining validated quality of life questionnaires in the various languages required.
This may cover postage of trial supplies to international sites, original CRFs to the co-ordinating centre, shipping of samples from sites to laboratories.
It is recommended that additional funding is included within international trials to cover site initiations, site visits and investigator meetings.
Payments from the grant to parties outside of the UK e.g. participating sites, international spokes may be subject to different taxes to what is standard in the UK.
If monitoring is required, travel costs will need to be included. It may be that it is more appropriate to use a local CRO to conduct site monitoring which may significantly increase costs. It is recommended that detailed discussions are held with relevant CROs ensuring it is clear what tasks are required and timelines for these so an appropriate quote can be obtained.