Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality

Abstract

Objectives: To analyze the current situation of cross-border access to clinical trials in the EU with an overview of stakeholders' real-life experience, and to identify the needs, challenges, and potential for facilitation of cross-border access. Methods: We employed a mixed methods design. Semi-structured interviews and an online survey were conducted with a wide range of stakeholders: patient representatives, investigators/physicians, policy and regulatory experts, academic and commercial sponsor representatives, ethics committee members. Interviews underwent a framework analysis. The survey was analyzed descriptively. Results: Three hundred ninety six individuals responded to the survey. The majority were investigators/physicians (46%) and patient representatives (33%). Thirty eight individuals were interviewed. The majority were investigators/physicians (29%) and patient representatives (29%). All European regions were represented in the study. The highest response rate was received from residents of Western European countries (38% of survey respondents, 45% of interviewees), the lowest from Eastern Europe (9% of survey respondents, 5% of interviewees). The study suggested that cross-border participation in clinical trials occurs in practice, however very rarely. Ninety two percentage of survey respondents and the majority of interviewees perceived as needed the possibility to access clinical trials abroad. However, most interviewees also opined that patients ideally should not have to travel in order to access experimental treatment. 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. The logistical and financial burden for patients was perceived as the biggest challenge. Different stakeholders expressed diverging opinions regarding the allocation of financial and organizational responsibility for enabling cross-border access to clinical trials. Participants provided a number of proposals for improving the current system, which were carefully evaluated by the research team and informed future recommendations. Conclusions: Participation in clinical trials abroad is happening rarely but should be facilitated. There was a consensus on the need for reliable and accessible information regarding practical aspects, as well as multi-stakeholder, multinational Lalova et al. Cross-Border Access to Clinical Trials recommendations on existing options and best practice on cross-border access to clinical trials. Broader interdisciplinary research is recommended before discussing options in the EU legislative framework to enable clearly defined conditions for cross-border access to clinical trials.

Crossing barriers: the burden of inflammatory bowel disease across Western Europe

“…96,101 One of the greatest barriers for patients to access clinical trials across borders is the exclusion of patients' right to receive medical care and claim reimbursement for clinical trial participation in another European country as per the scope of the Directive on the application of patients' rights to cross-border healthcare. 102 Lalova et al 103 conducted a pan-European survey that demonstrated that patients were interested in participating in clinical trials abroad with the strongest reasons to access a new treatment that is either not marketed or unavailable in a similar trial in their own country of residence. This study also found that the primary reason for hesitation to enter cross-border trials were logistical and financial burdens, including travel distance and expenses, accommodation, translation services, loss of income and the costs of baseline therapy when the experimental treatment was an add-on.…”

“…Another obstacle is that the home country's health insurance system may refuse to fund follow-up care services for patients who had access to experimental treatment abroad. 103 It is well known that encouraging a research-positive culture in health and care organisations not only improves patient access to clinical research and new treatment options, but has also demonstrated (1) better overall patient outcomes, (2) a happier workforce and (3) provides benefits for the healthcare systems. 105 Improved patient outcomes include reduction in mortality rates 106,107 and improved cancer survival outcomes.…”

A unique hub‐and‐spoke model to optimize patient management in lymphoma using novel CAR‐T cell therapy in Southeast and South Asia

“…Sharing of knowledge and healthcare resources across regional and international borders can facilitate patient access to treatments, 3,4 and help develop clinical capability and expertize. Examples of international cross-border collaboration throughout Asia include the Asia-Pacific Bone Marrow Transplantation Group (APBMT), which was established in 1990 to promote collaboration and share information about hematopoietic stem cell transplantations, and now includes 22 countries; and the Federation of Asian Organizations for Radiation Oncology, established in recognition of the lack of treatment centers and radiation machinery, and a deficit in technology in the region.…”

Management of patients with rare adult solid cancers: objectives and evaluation of European reference networks (ERN) EURACAN

“…Conversely, the CPMS may be adapted to the presentation of ultrarare cancer cases, in particular those with an incidence of 1/10 million per year. 17 , 38 …”

“…However, European legal clarifications and/or guidelines are very much needed to facilitate access to cross-border clinical trials, including in the field of paediatric research. 38 …”