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 (3

SUBMITTER: Lalova T 

PROVIDER: S-EPMC7642582 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature