Joint model |
Home country only |
Sponsor only |
EU |
(a) Home and host country. Example: the home country could organize a system for instructing the patients on practical matters related to joining a clinical trial abroad, while the host country could organize accommodation for foreign patients. |
(a) Via a “foreign office” in treating hospitals that would organize travel, accommodation, and insurance matter |
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Via a specifically designated EU organization, or through other appropriate means. |
(b) Home and host country, in collaboration with the ERNs (for patient referral). |
(b) Via a “special navigator” appointed by the treating hospital to guide each patient seeking to participate in a clinical trial abroad. |
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(c) Home country, supported by other interested stakeholders. Example: patient organizations |
(c) Via the NCPs. |
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(B) Cost coverage |
Sponsor only (regardless commercial or academic) |
Different responsibility for commercial and academic sponsors |
Joint model (regardless whether the sponsor is commercial or academic) |
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(a) Commercial sponsor: to cover all additional costs |
(a) Support by the home country. |
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(b) Academic sponsor: to be supported by the patient's home country. Example: each country could allocate a specific budget for the enabling of cross-border access to clinical trials. |
(b) Support by a special EU fund. Example: One interviewee (F) suggested how to collect resources for this fund–either by re-distributing money from EU's research funds, or by imposing a fee to commercial sponsors for this purpose. |
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(c) Support by the host country. |