Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation.

Real-world data (RWD) and real-world evidence (RWE) appear now as complementary to traditional randomized controlled trials (RCT), that remain the gold standard of the evidence. This review aims to illustrate how health authorities in France, United States (USA) and United Kingdom (UK) can integrate RWD and RWE in market authorization discussions and in new pathways of price and reimbursement negotiations. We conducted a review from the literature, online investigations and interviews.

A brain-computer interface for the continuous, real-time monitoring of working memory load in real-world environments.

We developed a brain-computer interface (BCI) able to continuously monitor working memory (WM) load in real-time (considering the last 2.5 s of brain activity). The BCI is based on biomarkers derived from spectral properties of non-invasive electroencephalography (EEG), subsequently classified by a linear discriminant analysis classifier.