Faint Hopes of Dispelling the Fog Around Cross-Border Trials in Europe

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Applied Clinical TrialsApplied Clinical Trials-05-01-2024
Volume 33
Issue 5

A forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.

While Europe is habitually under attack from Big Pharma for the latter's assertions of failing to encourage clinical trials, patients and carers have now joined the chorus, highlighting the challenges they face in accessing trials in Europe, and particularly studies that are conducted outside their own member state.

Campaigners claim overwhelming support among patients, carers, investigators, and sponsors for opening up the opportunities for so-called cross-border trials, and are increasingly determined to ease the blockages. But a workshop of prominent stakeholders in Brussels in mid-April made clear how remote this prospect still is, particularly for those in the greatest need. As Bettina Ryll, a leading Swedish advocate of melanoma care, put it, this remains “a financial, logistic, and mental burden”—and where patients occasionally succeed, it is, she added, because they are “proactive, highly educated, rich, or well-connected.”

According to EU-X-CT, a recent initiative aiming to improve the situation and that organized the Brussels workshop, although joining a clinical trial abroad is theoretically possible in the EU, “there is no specific legislation or guidance to facilitate cross-border participation.” This leaves navigation of the multiple legal, regulatory, and ethical barriers up to individuals—an evident hazard for patients with a life-threatening condition, or a rare disease, where a trial might represent the only therapeutic option.

For example, Institute Curie in France refused to accept Dutch patients into a uveal melanoma trial, because “with no French health insurance there was no access to the trial,” recounted Ryall. Coverage of healthcare costs and liability are among the principal obstacles identified, compounded by costs of travel and accommodation in the host country, ethics committee approvals, and the countless administrative issues—all further complicated by that quintessentially European challenge of more than 20 languages.

Since EU-X-CT kicked off in early 2023, its surveys have confirmed that patients and investigators have little knowledge about the options, and that information is hard to find. Now, with a target date of late 2024, it is planning to cut through the uncertainties on how the situation could be improved, and is stepping up its attempts to obtain a clearer view of the obstacles from regulators, investigators, payers, and patients.

Elmar Nimmesgern of the European Commission’s research department shared his doubts about how far current legislation on cross-border health could contribute, and was cautious about the implications of changing of the rules. Industry can offer little guidance at present, admitted Susan Bhatti of Merck BV, who is the chair of the European industry’s clinical research expert group. Cases have been so rare that there is as yet no central compilation of data, she said. And Ingrid Klingmann of Pharmaplex, who is a leading figure in EU-X-CT, conceded that overtures to insurance organizations and other payers had so far generated little response and less information.

But Marianne Lunzer of the Austrian Medicines and Medical Devices Agency, who is a co-chair of the European Clinical Trials Coordination Group, lent her backing during the meeting to a check with other national authorities. Monique Al of the Dutch Central Committee on Research involving Human Subjects, and a co-chair of the EU coordination committee for ethics committees, MedEthicsEU, similarly recognized that, even for her, there were many unknowns about the role of ethics committee in cross-border trials, and indicated readiness to explore arrangements among her European colleagues.

“It’s also about fairness,” pleaded Emilie Prazakova of Roche toward the end of the workshop.Patients in central and eastern Europe—the generally less wealthy member states—already have limited access to new medicines, and their possibilities depend largely on clinical trials. But most studies take place in the western EU countries. So to have any chance, individual patients must break through a mass of barriers, and not least, she added, “You need English.”

By coincidence, the same day that the workshop was highlighting the challenges for patients, the European Commission’s senior official for health, Sandra Gallina, addressing a workshop in Rome, boasted of the right of patients to access healthcare in another EU member state—and stressing that this must be achieved, “ in an easy and safe way.” On the same day, at the European Medicines Agency in Amsterdam, the head of the EU’s new authority for emergency health supplies, the Health Emergency Preparedness and Response Authority, was discussing his agenda. The long to-do list included “coordination of clinical trials.” And Europe resounds almost every day with proclamations of “my health, my right” from health commissioner Stella Kyriakides.

Not for the first time, Europe's ambition is outstripping its current achievements.

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