Presentation (CTI)

OBJECTIVES: To inform the development of a harmonized European Union (EU) Early Feasibility Studies (EFS) Program, at the centre of a Horizon JU IHI project, we collected the perspectives of different stakeholders involved in pre-market clinical investigations (CIs) of medical devices (MDs) on challenges and barriers faced, as well as solutions to improve and promote clinical research in the EU.
METHODS: Online survey for technology developers; open-ended interviews with representatives of EU HTA agencies, notified bodies, clinical sites, scientific associations, national ethics committees, technology developers (including SMEs); focus group with patient advisory group (PAG) of the project and patient associations.
RESULTS: According to survey respondents, the EU is the preferred location for conducting pre-market CIs. Crucial preference factors refer to trialists' and clinical site teams' competencies, the site's ability to enroll patients, and the time from study submission to first patient enrolled. A main barrier identified by stakeholders involved in CIs is the lack of dialogue between stakeholders, which makes the complexity of the regulatory framework even greater and requirements more difficult to follow. Risk-benefit analysis and device risk assessment were also deemed as major hurdles, together with aspects related to clinical sites (for instance, their experience in pre-market CIs), study design, study endpoints, enrolment targets, the lack of clear templates and guidance. Main obstacles encountered by patients during clinical trials were represented by fragmented information about the study and insufficient time and information to carefully assess the risks and benefits of participating in the study.
CONCLUSIONS: The discussion with all stakeholders clearly shows the multifaceted hurdles faced when bringing medical innovation to market and suggests actions for improvement, such as fostering early collaboration to improve clarity and reduce delays.