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

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...