Contribution of Methodologies Adapted to Clinical Trials Focusing on High Risk Medical Devices

Abstract

: High risk medical devices clinical trials are complicated, expensive, time-consuming and need an improved clinical evaluation with better scientific evidence throughout the European Union. The purpose of this study is to identify methodologies whose use could facilitate the evaluation of the medical device. Adaptive methods and Bayesian approaches are expert tools that can accelerate access to innovation providing more flexibility but they are insufficiently used because of a lack of expertise and training in the trial community (clinicians, statisticians and regulation authorities). Involving stakeholders (regulation authorities, industrial, clinicians, biostatisticians, end-users) early in the conceptualization of the adaptive design improve adoption, implementation, feasibility and overall quality of that trial.