Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

• DOI: 10.12688/f1000research.13585.1
• Publication Date: 2018-01-25T09:20:11Z
• Authors: Sajan Khosla; Robert White; Jesús Medina; Mario Ouwens; Cathy Emmas; Tim Koder; Gary Male; Sandra Leonard
• Keywords: Rigour; Viewpoints

<ns4:p>Stakeholders in healthcare are increasingly turning to real world evidence (RWE) inform their decisions, alongside from randomized controlled trials. RWE is generated by analysing data gathered routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness safety, health economic value impact. Recently, US Food Drug Administration European Medicines Agency have stated ambition for greater use of support applications new indications, now consulting with stakeholders formalize standards expected methods generating RWE.</ns4:p><ns4:p> Pharmaceutical companies responding increasing demands developing processes each stage generation pathway. Some conventions already place assuring quality, whereas other specific research question sources available. As becomes a core role medical affairs divisions large pharmaceutical companies, rigour will continue evolve improve. Senior leaders drive this change making element corporate strategy, top-level direction on how respective should approach maximum quality.</ns4:p><ns4:p> Here, we describe current future application within industry, necessary access generate RWE, challenges communicating RWE. Supporting building viewpoints industry publicly funded research, our perspective that at generation, quality critical impact has decision-makers; not only where an established evolving tool, but also potential disrupt improve drug development pathways.</ns4:p>