Table 4.
Interviewees' proposals for actions that could facilitate cross-border participation in clinical trials.
| Suggestions that directly address cross-border access to clinical trials | |
|---|---|
| Multi-stakeholder and multi-national recommendations with pragmatic solutions | •Should ideally have the status of official guidance issued or at least endorsed by an EU body, such as the European Commission or the European Medicines Agency (EMA). •Guidance development should involve all stakeholders, with patient organizations the preferred lead. |
| European Commission clarifying note on the Cross-border Healthcare Directive | •To include clinical research in the scope of the Directive. |
| Mixed model: issuing of multi-stakeholder recommendations with pragmatic solutions coupled with a change in the legislation applicable to clinical trials | •Interviewees did not provide any concrete examples as to how the legislation should be changed. |
| Setting up discussions between key stakeholders | As a first step toward the creation of the multi-stakeholder recommendations. Three types of discussions were proposed: 1. Discussions to clarify the role and allocation of responsibilities of different stakeholders involved in cross-border participation in clinical trials; 2. Discussions between sponsors and sites to actively foresee the feasibility for recruiting foreign patients; 3. Discussions exclusively related to a future political uptake of the issue. |
| Optimization of the ways relevant information is disseminated | •Establishing more optimal and user-friendly methods to inform patients about ongoing clinical trials. •National authorities to provide more and better-structured information about clinical trials. •Establishing conditions for higher awareness for treating physicians with respect to enrolling clinical trials. •More optimal use of digital services on EU and national level. |
| Creating a pan-European multidisciplinary tumor board or national tumor boards/expert panels | To provide a new assessment of treatment options for patients who have exhausted all available standard of care options, and to refer to suitable clinical trials at home, or abroad. |
| Establishing a stronger role for the European Reference Networks | |
| Negotiating bi-lateral agreements between neighboring countries defining the conditions for cross-border participation in clinical trials | |
| Utilizing the existing system of National contact points | •For provision of logistical and informational support for cross-border participation in clinical trials; |
| Establishing an EU fund | •To support financially cross-border participation in clinical trials. |
| Establishing an EU organization | •To provide support on EU level for cross-border participation in clinical trials. |
| Encouraging local treating physicians to refer patients to clinical trials | No concrete suggestions were provided on how this should happen in practice. |
| Establishing and regulating a stronger role for patient organizations | •With respect to: •provision of information •provision of logistical support •political uptake of the issue |
| Encouraging Member States to follow the example of Denmark and allow the use of the S2 form for clinical trials | |
| Local pre-screening of patients for inclusion in a trial | Making the opportunity for it available. |
| Suggestions that indirectly address cross-border access to clinical trials | |
| Regulating and supporting the performance of remote/decentralized clinical trials | |
| Harmonization of the EU framework for clinical trials, which would allow the opening of more pan-EU clinical trials | |
| Creation of a common ethical approval framework in the EU | |