Real-World Reluctance? Despite Guidance, Drug Developers Wary Of RWE-Based Trials

Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.

Medical Science Concept - Doctor in hospital lab with research icons in modern interface showing symbol of medicine innovation, treatment, discovery and healthcare analysis. - Image
Real-world data from health records may be used as a control in some clinical trials. • Source: Shutterstock

Regulators around the globe have released guidances to encourage biopharmaceutical firms to use real-world evidence strategies, but with hundreds of millions of dollars in research and development spending at stake for a single drug, companies are reluctant to walk away from traditional randomized, controlled clinical trials – even if substituting a typical control arm with an analysis of real-world data has the potential to save time and money.

Interest in real-world evidence (RWE)-based clinical trial strategies is growing, with biopharma companies considering such study designs more frequently now than they did a year ago, thanks to new guidance documents from regulators, Michelle Hoiseth, chief data officer at the contract research organization Parexel International Corp

More from Clinical Trials

More from R&D