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US FDA ‘Thinking Deeply’ On ‘Digital Twins’ As Placebo Control, But OCE Not Quite Ready To Embrace It

 
• By Kate Rawson

Oncology staff also said more work is needed before patient registries can be used as an external control in clinical trials, but they strongly encouraged continued investment.

digital twins
Oncology trial control arms might need to stay IRL in the near term. (Nielsen Hobbs; the Pink Sheet | Shutterstock images)

The Oncology Center of Excellence says it is open to considering the use of artificial intelligence-powered “digital twins” as an alternative to human placebos in clinical trials, but OCE is not quite ready to fully endorse its use while the US Food & Drug Administration is still considering its overall regulatory policy.

Key Takeaways
  • “Digital twins” – creating an AI model of a patient to predict behavior – remain under consideration for control arms in oncology trials, FDA says.

“The use of digital twins is something that FDA is still thinking very deeply about at a policy level,” Center for Drug Evaluation & Research’s Office of Biostatistics Division of...

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