Future ready real world data for healthcare optimisation and evidence-based decision making (Preprint)

Abstract

The life science industry is facing increasing pressure to demonstrate value of its innovations beyond product safety and efficacy studied in traditional clinical trials, which is hampered by limited access to readily available, well-characterised patient data generated during routine clinical care. The purpose of this paper is to describe how future structure, content, and availability of healthcare data can improve patient access to new therapeutics and industry’s possible role in overcoming the challenges around data characterisation, governance and transparency in order to fully leverage the value of real world evidence (RWE) for patients, doctors, health systems and other stakeholders.