Borders should not be barriers for trial participation according to industry group EUCROF, which has lauded the recent EFGCP and EFPIA initiative to help EU patients take part in trials in other member states as a positive move.
The initiative – here – is designed to support patient communities, investigators and sponsors in enabling cross-border access to clinical trials, which can be challenging at present due to a lack of rules on participation according to EUCROF.
“There is no European Union (EU) legal framework that defines the conditions to access clinical trials in another EU country.
“To support patients, investigators, and sponsors in enabling cross-border access to clinical trials, EFGCP and EFPIA have launched this initiative and representatives from patient organizations, industry, academia, CRO and medical society will work together with the objective of ‘Borders are no longer Barriers’ to make cross-border access a reality for patients.”
Participation framework
The view is in keeping with the findings of a 2020 study looking at cross border study participation which suggested “that cross-border participation in clinical trials occurs in practice, however very rarely.”
According to the study – which was based on a stakeholder survey - the lack of access to treatment in the home country of the patient was described as the main motivation to participate in a clinical trial in another country.
Respondents also suggested the logistical and financial burden for patients is biggest challenge.
The EFGCP and EFPIA initiative – known as EU-X-CT - will set out to identify the legal, financial, and operational challenges that potentially impede participation in clinical trials taking place in other EU states.
Representatives from patient organizations, academia, industry, contract research organizations (CROs) and medical societies will be asked to take part in specific working groups tasked with collecting and mapping information about trials in the EU.
The initiative is being supported by EFPIA with an unrestricted grant. However, other participating organizations will be invited to provide additional financial support.
The program will run for two years with EFGCP and EFPIA expected to present their final recommendations in 2025.
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