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

 
• By Mandy Jackson
  
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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.

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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...

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