EU cancer group calls for better cross-border access to clinical trials
A bilateral national approach could help bring clinical trials closer to cancer patients, a new study has shown.
Cancer patients living in the EU who are unable to access clinical trials for new treatments in other Member States, was the focus of discussion during the European Cancer Organisation (ECCO) Summit on Friday in Brussels.
Lack of cross-border access to clinical trials was the subject of a recent study looking at the challenges faced by cancer patients seeking treatments in other EU Member States.
The study was carried out by researchers from the European Forum for Good Clinical Practice (EFGCP), the European Organisation for Research and Treatment of Cancer (EORTC), KU Leuven and Patvocates, with the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The research, which was conducted in 15 countries with people from seven different stakeholder groups, comprised interviews and an online survey which yielded almost 400 responses – one third of which were from cancer patients or advocates.
EORTC research fellow Teodora Lalova, who was presenting the study’s findings at the Summit, said, “Better cross-border access to clinical trials is needed.”
Clinical trials, where new and innovative treatments such as vaccines, drugs and medical devices are tried and tested, are usually limited to specific hospitals and countries and rarely across national borders.
Consequently, patients seeking to be part of a new trial often have to access treatment themselves, without the advice or support of their local health service.
Currently, the only legislation in this area is the EU directive on patients’ rights in cross-border healthcare, which sets out the conditions under which a patient may travel to another EU country to receive medical care and reimbursement.
However, the study says that the legislation doesn’t go far enough in providing cancer patients with the information and support needed to access innovative treatment across borders.
According to Lalova, many of the patients they interviewed as part of the study said that the current system needs to be improved.
“The main motivation for seeking cross-border treatment is access to a new therapy that is not available in the home country” Teodora Lalova, EORTC research fellow
The report also found that people travel abroad for care primarily because treatment is not available in their home country.
“The main motivation for seeking cross-border treatment is access to a new therapy that is not available in the home country” said Lalova.
However, travelling abroad for treatment is not without its challenges. Lalova cited logistical and financial burdens, travel distances, language barriers, the uncertainty of eligibility, ethical requirements, and psychological burdens.
But changes to EU legislation would only deliver part of the solution, said Lalova, who also outlined alternative ways to resolve the problem.
This could involve establishing bilateral agreements between EU Member States on conditions for cross-border participation and addressing wider issues by bringing clinical trials closer to patients.
She also pointed out the need for the wider use of eHealth records across the EU to ease the eligibility of patients in other Member States.
“The simplification of the EU Clinical Trials Framework is also crucial”, she added.
As for the next steps, she said the EORTC research group will put forward guidelines, towards the end of this year, including best practices on how to deal with cross-border access as part of a call to action.
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