Trial Participation Across Borders
It is a clear and distinct political goal that patients should have the opportunity to participate in new and experimental treatment (clinical trials). For that reason, it is also desirable to cooperate across national borders by arranging for patients to be given the opportunity to participate in trials carried out abroad. A prerequisite for this, however, is that the costs of such participation are agreed in advance and that the responsibility of the patients for any unforeseen events is handled and clarified in separate agreements.
In commissioned (industry sponsored) clinical trials, there are no formal barriers preventing sponsor from paying for the participation of patients with affiliation to another hospital/country. In such cases, the costs for trial participation shall be regulated in the trial agreement as usual, i.e. that the sponsor assumes responsibility for paying all costs in connection with the trial, including necessary travel and accommodation. In addition, it is important that a clear and distinct agreement/declaration of responsibility, for handling unforeseen circumstances and unexpected expenses that are not directly related to the trial, is made between the submitting hospital (where the patient belongs) and the receiving hospital (where the study is conducted). Once this is established, the financial and legal framework for such inclusion and participation will be in place.
When including foreign patients in commissioned trials at OUS, the following applies:
- Hospital/trial unit must ensure that payment for foreign patients is included in the trial budget and the agreement with sponsor
- For the inclusion of a foreign patient, the hospital/trial unit must obtain an agreement/declaration from the submitting hospital that they will bear any extra/unexpected costs associated with transport and required treatment during the patient's stay at the trial unit
- The PI is responsible for emphasizing in the medical record that the stay for the foreign patient applies to a clinical trial. This is to ensure that the patient does not appear on the usual DRG overviews.
A template has been prepared for an agreement/declaration between the submitting hospital and OUS, which can be downloaded here:
The International Centre at OUS can provide assistance with entering into a guarantee agreement. They can also take on responsibility for invoicing any costs related to complications, however this is not mandatory if the division wants to handle invoicing by itself. The International Centre should be notified in advance of foreign clinical trial participants at OUS.
Study participants from abroad are covered by the same insurance schemes as Norwegian participants.
Contact information to the International Centre:
Phone: +47 22118111
Telephone hours: Normal office hours, weekdays
Mail address:
Oslo universitetssykehus HF
Utenlandskontoret
Direktørens stab
Postboks 4950 Nydalen
NO-0424 Oslo