Is Real-World Data The Real Deal?

By Liisa A. Palmer, PhD, Portfolio Leader, HEOR Services

Individuals who spend time around clinical trial sponsors are likely to hear the words “real-world data” discussed as a kind of cure-all for creating more efficient trials. While real-world data has shown tremendous potential since it was first cleared for use by the FDA in 2016 through the Cures Act, its role in trials today often remains more aspirational than actual. If real-world data is really so effective, why aren’t more contract research organizations (CROs) using it? The problem stems in part from the fact that real-world data can mean a lot of different things, not all of which are well-suited to clinical trials depending on their scope and objective.